Panels › Orthopedic › Product code KWQ · Class 2
Appliance, Fixation, Spinal Intervertebral Body
Regulation 888.3060
11510(k)s in 12 months (668 all time)
1recalls in 12 months (214 all time)
165recalls that name a 510(k)
Top companies in KWQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Spine | 6 | 38 |
| Alphatec Spine, Inc. | 9 | 32 |
| RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | 0 | 41 |
| Zimmer, Inc. | 1 | 37 |
| Medtronic Sofamor Danek | 29 | 8 |
| Nuvasive, Inc. | 21 | 0 |
| K2m | 20 | 0 |
| Depuy Spine, Inc. | 10 | 8 |
| Blackstone Medical, Inc. | 13 | 3 |
| Globus Medical, Inc. | 15 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 29, 2015 | Alphatec Spine, Inc. 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm
Alphatec Spine
Solutions for the Aging Spine
Trestle Luxe Anterior Cervical Plating System
REF 71240-14
LOT XXXXXX
Alphatec Spine, Inc.
EN: 4 Terminated |
KWQ | K102820 |
| Sep 22, 2014 | Synthes, Inc. DePuy Synthes TI Vectra Plates:
TI Vectra-One" Plate 2 Level / 34 mm
part 04.613.184
3337672
TI Vectra" Plate 3 Level / 57 mm
part 04.613.257
lot 3693878
TI Vectra" Plate 4 Level / 64 mm
part Terminated |
KWQ | K050451 K071667 |
| Feb 25, 2014 | Orthofix, Inc Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only
The Azure Anterior Cervical Plate System is a temporary implant, intended for an Terminated |
KWQ | K130825 |
| Dec 26, 2013 | SpineFrontier, Inc. Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling.
Used to secure the Invue Anterior Cervical Plate in position. Terminated |
KWQ | K121060 |
| Dec 26, 2013 | SpineFrontier, Inc. Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping.
Used to secure the Invue Anterior Cervical Plate in position. Terminated |
KWQ | K121060 |
| Dec 26, 2013 | SpineFrontier, Inc. Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling.
Used to secure the Invue Anterior Cervical Plate in position. Terminated |
KWQ | K121060 |
| Dec 26, 2013 | SpineFrontier, Inc. Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered.
Used to secure the Invue Anterior Cervical Plate in position. Terminated |
KWQ | K121060 |
| Nov 18, 2013 | Zimmer, Inc. Trinica Anterior Lumbar Plate (ALP) system, part 07.01058.001. Non Sterile, Rx only. The Trinica Anterior Lumbar Plate System is a temporary supplemental fixation device consisting of a variety of sh Terminated |
KWQ | K061353 |
| May 27, 2013 | Spinal Solutions, LLC Fang Screw 20mm
Fang Plate 21mm
Product Usage:
Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for u Terminated |
KWQ | K090415 |
| Mar 8, 2013 | Genesys Orthopedic Systems, LLC 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System
Product Usage: is intended for anterior screw fixation to the cervical spine. Terminated |
KWQ | K111132 |
| Feb 4, 2013 | Synthes USA HQ, Inc. Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012.
Synthes Vectra System, Synthes Vectra-One System and Synth Terminated |
KWQ | K050451 K051665 +1 |
| Feb 4, 2013 | Synthes USA HQ, Inc. Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011.
Synthes Vectra System, Terminated |
KWQ | K050451 K051665 +1 |
| Oct 10, 2012 | Medtronic Sofamor Danek USA Inc PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.
Orthopedic.
This instrument Terminated |
KWQ | K021461 K063100 +1 |
| Oct 10, 2012 | Medtronic Sofamor Danek USA Inc ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.
Orthopedic.
Th Terminated |
KWQ | K021461 K063100 +1 |
| Oct 10, 2012 | Medtronic Sofamor Danek USA Inc ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.
Orthopedic. Terminated |
KWQ | K021461 K063100 +1 |
| Aug 27, 2012 | Alphatec Spine, Inc. TRESTLE LUXE Anterior Cervical Plating System, Product code KWQ. 510(k) K102820.
The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bo Terminated |
KWQ | K102820 |
| May 23, 2012 | Captiva Spine, Inc Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part:
"***Part Number CP50150***Single Barrel Variable Drill Guide***Lot Number 1500705A or Lot Number Terminated |
KWQ | K073708 |
| May 23, 2012 | Captiva Spine, Inc Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part:
"***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***"
"***Part Number CP40014* Terminated |
KWQ | K073708 |
| May 14, 2012 | Captiva Spine, Inc Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The SmartLOX Cervical Plate System components are supplied clean and not sterile. All implants and i Terminated |
KWQ | K073708 |
| Apr 25, 2012 | Aesculap Implant Systems Quintex Cervical Plating System - Screws. The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability. The Quintex Cervical Screws are available in three different Terminated |
KWQ | K100243 |
| Jan 11, 2012 | Medtronic Sofamor Danek USA Inc CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis Terminated |
KWQ | K042025 |
| Jan 11, 2012 | Medtronic Sofamor Danek USA Inc CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X0809439, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memph Terminated |
KWQ | K042025 |
| May 13, 2011 | Integra LifeSciences Corp. Manta Ray" Anterior Cervical Plate (ACP) System,
Intended use: The Manta Ray ACP System is an anterior cervical plate that is indicated for temporary stabilization of the cervical spine from C2-C7. Terminated |
KWQ | K080690 |
| Dec 10, 2010 | Zimmer Inc. Spinal Concepts snap-fix polyaxial screwdriver, Manufactured by Spinal Concepts, Austin, TX, REF 781-3. Terminated |
KWQ | K031985 K052247 +2 |
| Dec 10, 2010 | Zimmer Inc. Spinal Concepts polyaxial screwdriver II, Manufactured by Spinal Concepts, Austin, TX, REF 781-2. Terminated |
KWQ | K031985 K052247 +2 |
| Dec 10, 2010 | Zimmer Inc. Spinal Concepts polyaxial screw driver, Manufactured by Spinal Concepts, Austin, TX, REF 781-01. Terminated |
KWQ | K031985 K052247 +2 |
| Dec 10, 2010 | Zimmer Inc. Spinal Concepts polyaxial screw driver, AO, Manufactured by Spinal Concepts, Austin, TX, REF 775-01. Terminated |
KWQ | K031985 K052247 +2 |
| Oct 19, 2010 | Theken Spine Llc Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate Terminated |
KWQ | K080690 |
| Jun 2, 2010 | Alphatec Spine, Inc. Trestle Anterior Cervical Plate 1-level assembly, Part Number: 61001-026. Alphatec Spine, Carlsbad, CA 92008.
Intended for the temporary stabilization of the anterior spine during the development of Terminated |
KWQ | K070681 |
| May 26, 2010 | Blackstone Medical, Inc. Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070.
Non Sterile. Terminated |
KWQ | K050892 |
| Apr 12, 2010 | Stryker Spine Stryker Reflex Hybrid Screw Extractor Inner Shaft;
Not Sterile;
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ.
The threaded Terminated |
KWQ | K062310 |
| Apr 12, 2010 | Stryker Spine Stryker Reflex Hybrid Screw Extractor;
Not Sterile: Manufactured by: Stryker Spine SAS,
Cestas, France; Distributed in the USA by: Stryker Spine, 2 Pearl Court, Allendale, NJ.
The threaded tip of the Terminated |
KWQ | K062310 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.5 x 67MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.5 x 64MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.5 x 61MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.5 x 58MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.5 x 55MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.5 x 52MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.5 x 49MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.5 x 46MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.5 x 43MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.5 x 40MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Screw 6.5 x 37MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Screw 6.5 x 34MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Screw 6.5 x 31MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Screw 6.5 x 28MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Screw 6.5 x 25MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Screw 6.5 x 22MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.0 x 67MM, spinal implant component Terminated |
KWQ | K073437 |
| Nov 24, 2009 | Stryker Spine Stryker Thor Anterior Plating System;
Non Sterile
Thor Standard Long Screw 6.0 x 64MM, spinal implant component Terminated |
KWQ | K073437 |
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