Company ยท US
Depuy Spine, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2022. Name variants (Inc, Corp, punctuation) are merged.
71510(k) clearances (0 in 12 months)
57recalls (0 in 12 months)
44recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 40 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 18 |
| HWC | Screw, Fixation, Bone | 15 |
| NDN | Cement, Bone, Vertebroplasty | 10 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 8 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 6 |
| GCC | Dilator, Catheter | 5 |
| MQP | Spinal Vertebral Body Replacement Device | 4 |
| LRP | Tray, Surgical | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 |
| MNI | Orthosis, Spinal Pedicle Fixation | 3 |
| MQV | Filler, Bone Void, Calcium Compound | 3 |
| LYC | Bone Grafting Material, Synthetic | 2 |
| OCJ | Spinal Channeling Instrument, Vertebroplasty | 2 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 |
| HXC | Wrench | 1 |
| MRW | System, Facet Screw Spinal Device | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 |
| OUR | Sacroiliac Joint Fixation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2022 | K222276 | CONDUIT Cages; FIBERGRAFT BG Putty Depuy Spine | ODP |
| Aug 31, 2020 | K201831 | CONFIDENCE Spinal Cement System Depuy Spine, Inc. | NDN |
| Nov 19, 2014 | K142185 | EXPEDIUM VERSE SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Jun 14, 2012 | K111136 | EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEM Depuy Spine, Inc. | NKB |
| May 3, 2012 | K121020 | VIPER SYSTEM Depuy Spine, Inc. | NKB |
| Apr 7, 2011 | K110353 | MOUNTAINEER OCT SPINAL SYSTEM Depuy Spine, Inc. | KWP |
| Apr 1, 2011 | K110216 | EXPEDIUM SYSTEM, VIPER SYSTEM Depuy Spine, Inc. | NKB |
| Jan 18, 2011 | K103133 | VEPER SYSTEM, EXPEDIUM SYSTEM Depuy Spine, Inc. | NKB |
| Dec 7, 2010 | K101993 | VIPER SYSTEM, EXPEDIUM SYSTEM Depuy Spine, Inc. | NKB |
| Dec 1, 2010 | K101923 | CONCORDE CURVE SYSTEM Depuy Spine | MAX |
| Nov 17, 2010 | K103100 | MOUNTAINEER OCT SPINAL SYSTEM Depuy Spine, Inc. | MNI |
| Nov 15, 2010 | K101762 | VIPER F2 FACET FIXATION SYSTEM Depuy Spine, Inc. | MRW |
| Oct 20, 2010 | K102701 | VIPER SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Oct 18, 2010 | K101933 | MODIFICATION TO:EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| May 25, 2010 | K093390 | HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025 Depuy Spine, Inc. | LYC |
| Feb 4, 2010 | K100070 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM Depuy Spine, Inc. | KWQ |
| Jan 7, 2010 | K091994 | MOUNTAINEER LAMINOPLASTY SYSTEM Depuy Spine, Inc. | NQW |
| Nov 25, 2009 | K092473 | EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Sep 25, 2009 | K092626 | MODIFICATION TO: EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Jun 10, 2009 | K090648 | VIPER 2 SYSTEM Depuy Spine, Inc. | NKB |
| May 22, 2009 | K081917 | DEPUY SPINE BENGAL, CONCORDE, COUGAR, DEVEX AND LEOPARD SYSTEMS Depuy Spine, Inc. | MAX |
| May 19, 2009 | K090899 | DEPUY SPINE LATERAL SYSTEM Depuy Spine, Inc. | MAX |
| Apr 22, 2009 | K090799 | MODIFICATION TO EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Mar 6, 2009 | K090230 | EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Nov 14, 2008 | K082128 | DEPUY SPINE LATERAL CAGE SYSTEM Depuy Spine | MAX |
| Oct 31, 2008 | K082942 | MODFICATION TO: EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Sep 10, 2008 | K082273 | UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM Depuy Spine, Inc. | KWQ |
| Sep 10, 2008 | K081898 | EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Sep 3, 2008 | K082195 | MODIFICATIONS TO EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Sep 3, 2008 | K081758 | HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015 Depuy Spine, Inc. | MQV |
| Aug 29, 2008 | K081432 | HEALOS II BONE GRAFT SUBSTITUTE Depuy Spine, Inc. | LYC |
| Jun 27, 2008 | K080828 | MOUNTAINEER OCT SPINAL SYSTEM Depuy Spine, Inc. | MNH |
| May 30, 2008 | K081252 | EXPEDIUM 4.5MM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| May 15, 2008 | K073562 | MODIFICATION TO VIPER SPINE SYSTEM Depuy Spine, Inc. | NKB |
| May 8, 2008 | K080313 | MODIFICATION TO EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| May 1, 2008 | K080568 | X-MESH EXPANDABLE CAGE SYSTEM Depuy Spine, Inc. | MQP |
| Apr 4, 2008 | K073364 | EXPEDIUM 4.5MM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Apr 2, 2008 | K080191 | EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM Depuy Spine, Inc. | KWQ |
| Jan 25, 2008 | K073649 | BENGAL STACKABLE CAGE SYSTEM Depuy Spine, Inc. | MQP |
| Dec 6, 2007 | K073126 | EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Oct 5, 2007 | K072546 | SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM Depuy Spine, Inc. | KWQ |
| Sep 18, 2007 | K070387 | EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Aug 1, 2007 | K071860 | MODIFICATION TO: VIPER SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Jul 10, 2007 | K063772 | EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| May 9, 2007 | K070994 | EAGLE + ANTERIOR CERVICAL PLATE SYSTEM Depuy Spine, Inc. | KWQ |
| Apr 10, 2007 | K070300 | EXPEDIUM SFX CROSS CONNECTOR SYSTEM Depuy Spine, Inc. | KWP |
| Jan 17, 2007 | K063741 | EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Dec 15, 2006 | K062814 | PIPELINE II ACCESS SYSTEM Depuy Spine, Inc. | GZT |
| Nov 22, 2006 | K063156 | MODIFICATION TO EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | NKB |
| Nov 2, 2006 | K062174 | MODIFICATION TO EXPEDIUM SPINE SYSTEM Depuy Spine, Inc. | MNH |
Newest 50 of 71.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2022 | DePuy Spine, Inc. EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD)
Part Number: CUI Open, Classified |
MAX | K170503 |
| May 20, 2022 | DePuy Spine, Inc. EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD).
Part Number: CUI Open, Classified |
MAX | K170503 |
| Apr 27, 2019 | DePuy Spine, Inc. Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L) Terminated |
MAX | K152156 K160464 |
| Apr 27, 2019 | DePuy Spine, Inc. Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C) Terminated |
MAX | K171425 |
| Dec 15, 2017 | DePuy Spine, Inc. Confidence Plus Kit Spinal Cement System, Product Codes: 283910000 (GTIN: (01)10705034209623) and 283910000 (GTIN: (01)10705034209630)
The CONFIDENCE SPINAL CEMENT SYSTEM 11cc Kit is intended for per Terminated |
NDN | K060300 |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm
Item Code: 186864018
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C Terminated |
KWQ | K052552 |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm
Item Code: 186862018
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to Terminated |
KWQ | K052552 |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm
Item Code: 186854018
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 fo Terminated |
KWQ | K052552 |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm
Item Code: 186852026
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 Terminated |
KWQ | K052552 |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm
Item Code: 186852020
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 Terminated |
KWQ | K052552 |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm
Item Code: 186852018
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to Terminated |
KWQ | K052552 |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm
Item Code: 186850018
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to Terminated |
KWQ | K052552 |
| Dec 21, 2015 | DePuy Spine, Inc. Aegis Torque Handle CATALOG NO. : 2871-10-800. A spinal surgical instrument used on the AEGIS Anterior Lumbar Plate System. Terminated |
KWQ | None listed |
| May 26, 2015 | DePuy Spine, Inc. EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467 Terminated |
NKB | K101070 K111136 +1 |
| Oct 23, 2013 | DePuy Spine, Inc. PIPELINE LS ACCESS SYSTEM, Holding Clip
The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. Terminated |
GCC | None listed |
| Oct 23, 2013 | DePuy Spine, Inc. PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated
The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Terminated |
GCC | None listed |
| Oct 23, 2013 | DePuy Spine, Inc. PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated
The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Terminated |
GCC | None listed |
| Oct 23, 2013 | DePuy Spine, Inc. PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated
The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Terminated |
GCC | None listed |
| Oct 23, 2013 | DePuy Spine, Inc. PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated
The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Re Terminated |
GCC | None listed |
| Sep 3, 2013 | DePuy Spine, Inc. CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000
The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixation Terminated |
NDN | K060300 |
| Sep 3, 2013 | DePuy Spine, Inc. CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000
The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for Terminated |
NDN | K060300 |
| Sep 3, 2013 | DePuy Spine, Inc. CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000
The CONFIDENCE Spinal Cement System is intended for percutaneous delivery of CONFIDENCE Spinal Cement, which is indicated for fixati Terminated |
NDN | K060300 |
| Mar 18, 2013 | DePuy Spine, Inc. DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT
Catalog Number: 283913000.
Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Terminated |
NDN | K060300 |
| Mar 18, 2013 | DePuy Spine, Inc. DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT
Catalog Number: 283910000.
Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Terminated |
NDN | K060300 |
| Mar 18, 2013 | DePuy Spine, Inc. DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT
Catalog Number: 283907000.
Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Terminated |
NDN | K060300 |
| Mar 18, 2013 | DePuy Spine, Inc. DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT
Catalog Number:283905000.
Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Terminated |
NDN | K060300 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl
Product Code: 1867-15-199
Spinal Implant Component. Terminated |
NKB | K101993 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl
Product Code: 1867-15-180
Spinal Implant Component. Terminated |
NKB | K101993 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl
Product Code: 1867-15-170
Spinal Implant Component. Terminated |
NKB | None listed |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl
Product Code: 1867-15-999
Spinal Implant Component. Terminated |
NKB | K101993 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl
Product Code: 1867-15-980
Spinal Implant Component. Terminated |
NKB | K101993 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl
Product Code: 1867-15-970
Spinal Implant Component. Terminated |
NKB | K101993 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl
Product Code: 1867-15-899
Spinal Implant Component. Terminated |
NKB | K101993 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl
Product Code: 1867-15-880
Spinal Implant Component. Terminated |
NKB | K101993 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl
Product Code: 1867-15-870
Spinal Implant Component. Terminated |
NKB | K101993 |
| Jan 16, 2013 | DePuy Spine, Inc. DePuy Spine EXPEDIUM Offset Torque Wrench
Product Code 2797-29-510
The device is intended for use during the final tightening of an Expedium Offset Spinal Construct. Terminated |
HXC | None listed |
| Apr 27, 2011 | DePuy Spine, Inc. Confidence Introducer Needle Side Hole 13G x 4-Inch
Product Code: 2839-04-413
The Confidence Needles are supplied sterile. They are used to place bone cement percutaneously at a desired location. The Terminated |
OCJ | None listed |
| Apr 27, 2011 | DePuy Spine, Inc. Confidence Diamond Tip Introducer Needle 11G x 6-Inch
Product Code: 2839-03-611
The Confidence Needles are supplied sterile. They are used to place bone cement percutaneously at a desired location. T Terminated |
OCJ | None listed |
| Dec 27, 2010 | DePuy Spine, Inc. Depuy Spine Mountaineer OCT Spinal System Screw Caddy, Non Sterile
Product Code: 2883-90-420
The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior Terminated |
LRP | None listed |
| Dec 27, 2010 | DePuy Spine, Inc. Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set, , Non Sterile
Product Code: 2883-90-400
The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screw Terminated |
LRP | None listed |
| Dec 27, 2010 | DePuy Spine, Inc. Depuy Spine Mountaineer OCT Caddy Set, Non-Sterile
Product Code: 2883-90-000
The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery Terminated |
LRP | None listed |
| Aug 14, 2009 | DePuy Spine, Inc. DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300.
Intended to provide immobilization and stabilization of spinal segments in skeletally mature patien Terminated |
KWP | K070300 |
| Nov 2, 2006 | DePuy Spine, Inc. HI Fix Skull Pins, DePuy Spine Bremer Halo System
Product Code: AC020 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Extra Long Skull Pins, DePuy Spine Bremer Halo System
Product Number: AC018 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Skull pins w/Torque, DePuy Spine Bremer Halo System
Product Code: AC014 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Standard Skull Rings, DePuy Spine Bremer Halo System
Product Code: AC007 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Large Pediatric Ring, DePuy Spine Bremer Halo System
Product Code: PT002 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Small Pediatric Ring, DePuy Spine Bremer Halo System
Product Code: PT001 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Adjustable Ring Traction Set, Size C, DePuy Spine Bremer Halo System
Product Code: HT002 Terminated |
HWC | K915800 K993099 |
| Nov 2, 2006 | DePuy Spine, Inc. Adjustable Ring Traction Set, Size B, DePuy Spine Bremer Halo System
Product Code: HT001 Terminated |
HWC | K915800 K993099 |
Newest 50 of 57.