Company ยท US
K2m, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
127510(k) clearances (3 in 12 months)
39recalls (0 in 12 months)
12recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HWJ | Awl | 24 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 20 |
| NKB | Thoracolumbosacral Pedicle Screw System | 20 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 16 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 15 |
| MNI | Orthosis, Spinal Pedicle Fixation | 15 |
| MQP | Spinal Vertebral Body Replacement Device | 8 |
| NKG | Posterior Cervical Screw System | 8 |
| OLO | Orthopedic Stereotaxic Instrument | 8 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 7 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | 6 |
| KNW | Instrument, Biopsy | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 |
| OWI | Bone Fixation Cerclage, Sublaminar | 3 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 |
| HRS | Plate, Fixation, Bone | 1 |
| JDQ | Cerclage, Fixation | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
| PGM | Growing Rod System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 17, 2026 | K260546 | Q Pedicle Instruments K2m, Inc. | OLO |
| Feb 10, 2026 | K253545 | Vulcan Spinal System K2m, Inc. | NKB |
| Feb 6, 2026 | K252873 | Q Interbody Instruments K2m, Inc. | OLO |
| Feb 24, 2022 | K211320 | CAPRI Corpectomy Cage System K2m, Inc. | PLR |
| Oct 26, 2020 | K202528 | Cannulated Power Driver Attachment K2m, Inc. | NKB |
| Aug 7, 2020 | K201006 | K2M Navigation Instruments K2m, Inc. | OLO |
| Feb 18, 2020 | K193203 | MOJAVE Expandable Interbody System K2m, Inc. | MAX |
| Feb 7, 2020 | K193129 | Yukon OCT Spinal System K2m, Inc. | NKG |
| Nov 14, 2019 | K192911 | Brainlab Compatible K2M Navigation Instruments K2m, Inc. | OLO |
| Oct 3, 2019 | K190179 | SAHARA Stabilization System K2m, Inc. | OVD |
| May 15, 2019 | K190584 | CAYMAN LP Plate System K2m, Inc. | KWQ |
| Dec 12, 2018 | K182473 | PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and K2m, Inc. | KWQ |
| Nov 28, 2018 | K180665 | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System K2m, LLC | MQP |
| Nov 15, 2018 | K182182 | YUKON OCT Spinal System K2m | NKG |
| Nov 9, 2018 | K181890 | Brainlab Compatible K2M Navigation Instruments K2m | OLO |
| Oct 5, 2018 | K181603 | EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUK K2m, Inc. | NKG |
| Aug 3, 2018 | K180777 | K2M Expandable Interbody System K2m, Inc. | MAX |
| Jun 26, 2018 | K181119 | Range (Denali and Mesa) Spinal Systems K2m, Inc. | NKB |
| May 30, 2018 | K181188 | EVEREST Spinal System K2m, Inc. | NKB |
| Apr 5, 2018 | K180376 | K2M Patient Specific Rods K2m, Inc. | NKB |
| Feb 12, 2018 | K172941 | CASCADIA Interbody System K2m | OVD |
| Jan 16, 2018 | K171556 | K2M Navigation Instruments K2m | OLO |
| Jan 9, 2018 | K173508 | Everest Spinal System K2m | NKB |
| Dec 14, 2017 | K172009 | Cascadia Interbody System K2m, Inc. | MAX |
| Sep 14, 2017 | K171832 | Range/Denali/Mesa Spinal System K2m, Inc. | NKB |
| Aug 31, 2017 | K171704 | CAPRI Corpectomy Cage System K2m | MQP |
| Aug 30, 2017 | K171321 | K2M Navigation Instruments K2m | OLO |
| Aug 23, 2017 | K172104 | Ozark(tm) Cervical Plate System K2m, Inc. | KWQ |
| Aug 8, 2017 | K171444 | YUKON OCT Spinal System K2m, Inc. | NKG |
| May 10, 2017 | K171097 | MOJAVE Expandable Interbody System K2m, Inc. | MAX |
| Apr 13, 2017 | K170055 | CAPRI Corpectomy Cage System K2m | MQP |
| Apr 5, 2017 | K161332 | NILE Proximal Fixation Spinal System K2m, Inc. | OWI |
| Mar 15, 2017 | K163364 | MOJAVE Expandable Interbody System K2m | MAX |
| Oct 7, 2016 | K162664 | Pyrenees Cervical Plate System K2m, Inc. | KWQ |
| Sep 21, 2016 | K162264 | Cascadia Interbody System K2m, Inc. | MAX |
| Jul 22, 2016 | K161028 | K2M Growing Spine System K2m, Inc. | PGM |
| Jul 21, 2016 | K161369 | EVEREST Spinal System K2m, Incorporated | NKB |
| Apr 27, 2016 | K153526 | Pyrenees Cervical Plate System K2m | KWQ |
| Apr 22, 2016 | K160125 | Cascadia Interbody System K2m | ODP |
| Mar 24, 2016 | K160547 | Cascadia Interbody System K2m | MAX |
| Mar 18, 2016 | K160208 | NILE Alternative Fixation Spinal System K2m, Inc. | OWI |
| Feb 16, 2016 | K153370 | Caspian OCT/MESA Mini/DENALI Mini Spinal System K2m, Incorporated | NKG |
| Jan 5, 2016 | K152872 | K2M Fenestrated Tap System K2m | KNW |
| Dec 21, 2015 | K151481 | Sahara Stabilization System K2m, Inc. | OVD |
| Nov 17, 2015 | K153031 | RANGE/DENALI/MESA Spinal System K2m, Incorporated | NKB |
| Sep 24, 2015 | K152281 | Pyrenees Cervical Plate System K2m | KWQ |
| Sep 17, 2015 | K151727 | Everest Spinal System K2m, Inc. | NKB |
| Sep 4, 2015 | K152015 | Pyrenees Cervical Plate System K2m, Inc. | KWQ |
| Aug 20, 2015 | K150481 | Cascadia Interbody System K2m, Inc. | MAX |
| Aug 10, 2015 | K151216 | Everest Spinal System K2m, Inc. | NKB |
Newest 50 of 127.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2022 | K2M, Inc. Yukon Straight Rod 4.0 x120mm;
Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments. Open, Classified |
KWP | K171444 |
| Jan 13, 2022 | K2M, Inc Everest MI XT Outer Dilator, Catalog Number 5101-90168 Open, Classified |
KWP | None listed |
| Jan 13, 2022 | K2M, Inc Everest MI XT Inner Dilator, Catalog Number 5101-90167 Open, Classified |
KWP | None listed |
| Sep 8, 2021 | K2M, Inc Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068 Terminated |
OVE | K142487 |
| May 7, 2021 | K2M, Inc Cascadia AN Interbody Convex 10x28x14mm
Catalog Number: 6101-2102814NC-G2
Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft compris Terminated |
MAX | K150481 K172009 |
| May 7, 2021 | K2M, Inc Cascadia AN Interbody Convex 10x22x15mm
Catalog Number: 6101-2102215NC-G2
Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft compris Terminated |
MAX | K150481 K172009 |
| May 7, 2021 | K2M, Inc Cascadia AN Interbody Convex 10x22x14mm
Catalog Number: 6101-2102214NC-G2
Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised Terminated |
MAX | K150481 K172009 |
| Mar 16, 2021 | K2M, Inc Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine)
Catalog number: 3608-90033 Terminated |
HRS | K111439 |
| Jan 27, 2021 | K2M, Inc Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System Terminated |
NKG | K171444 |
| Nov 4, 2020 | K2M, Inc Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrument back and forth until the entire tab is fully detached from th Terminated |
LXH | None listed |
| Nov 3, 2020 | K2M, Inc Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy wh Terminated |
NKG | K193129 |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90181, UDI # 10888857108943, Size 28x8mm, 18
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90179, UDI # 10888857108929, Size 28x6mm, 18
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90177, UDI # 10888857108905, Size 28x4mm, 18
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90169, UDI # 10888857108820, Size 28x10mm, 12
Product Usage: Used to simulate the h Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90167, UDI # 10888857108806, Size 28x8mm, 12
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90165, UDI # 10888857108783, Size 28x6mm, 12
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90163, UDI # 10888857108769, Size 28x4mm, 12
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90157, UDI # 10888857108707, Size 28x12mm, 6
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90155, UDI # 10888857108684, Size 28x10mm, 6
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90153, UDI # 10888857108660, Size 28x8mm, 6
Product Usage: Used to simulate the hei Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90151, UDI # 10888857108646, Size 28x6mm, 6
Product Usage: Used to simulate the hei Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90149, UDI # 10888857108622, Size 28x4mm, 6
Product Usage: Used to simulate the hei Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90139, UDI # 10888857108523, Size 24x8mm, 18
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90137, UDI # 10888857108509, Size 24x6mm, 18
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90135, UDI # 10888857108486, Size 24x4mm, 18
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90127, UDI # 10888857108400, Size 24x10mm, 12
Product Usage: Used to simulate the h Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90125, UDI # 10888857108387, Size 24x8mm, 12
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90123, UDI # 10888857108363, Size 24x6mm, 12
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90121, UDI # 10888857108349, Size 24x4mm, 12
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90115, UDI # 10888857108288, Size 24x12mm, 6
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90113, UDI # 10888857108264, Size 24x10mm, 6
Product Usage: Used to simulate the he Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90111, UDI # 10888857108240, Size 24x8mm, 6
Product Usage: Used to simulate the hei Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90109, UDI # 10888857108226, Size 24x6mm, 6
Product Usage: Used to simulate the hei Terminated |
HWJ | None listed |
| Apr 24, 2020 | K2M, Inc K2M, ALEUTIAN Interbody Spacer Systems, EN AN Lordotic Spreader, Stainless Steel, Non-Sterile, Qty 1, Catalog # 5203-90107, UDI # 10888857108202, Size 24x4mm, 6
Product Usage: Used to simulate the hei Terminated |
HWJ | None listed |
| Apr 18, 2019 | K2M, Inc Fenestrated Tap Adapter (REF# 5001-90011)
Product Usage:
The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for dia Terminated |
KNW | K152872 |
| Apr 18, 2019 | K2M, Inc Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015)
Product Usage:
The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone Terminated |
KNW | K152872 |
| Jul 24, 2018 | K2M, Inc YUKON Polyaxial Screws (3.5 X 12 mm, Owning Site: Leesburg USA
3.5 X 14 mm, 3.5 X 32 mm, 3.5 X 34 mm, 3.5 X 38 mm, 3.5 X 40 mm, 4.0 X 16 mm,
4.0 X 18 mm, 4.0 X 20 mm, 4.0 X 22 mm, 4.0 X 24 mm, 4.0 X 2 Terminated |
NKG | K171444 |
| Dec 2, 2016 | K2M, Inc K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor)
Product Usage:
Special Connector Instruments include an additional feature on their shafts that enable surgeo Terminated |
OLO | K171321 |