ClearanceBrief
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)
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Top companies in KWQ

DateFirm and productCodeLinked 510(k)
Apr 29, 2015Alphatec 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
KWQK102820
Sep 22, 2014Synthes, 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
KWQK050451
K071667
Feb 25, 2014Orthofix, 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
KWQK130825
Dec 26, 2013SpineFrontier, Inc.
Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
Terminated
KWQK121060
Dec 26, 2013SpineFrontier, Inc.
Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. Used to secure the Invue Anterior Cervical Plate in position.
Terminated
KWQK121060
Dec 26, 2013SpineFrontier, Inc.
Indus Invue Screws: lM71059-XX: Indus Screw 04.2mm SelfDrilling. Used to secure the Invue Anterior Cervical Plate in position.
Terminated
KWQK121060
Dec 26, 2013SpineFrontier, Inc.
Indus Invue Screws: IM71058-XX: 04.2mm, SelfTapping, Tapered. Used to secure the Invue Anterior Cervical Plate in position.
Terminated
KWQK121060
Nov 18, 2013Zimmer, 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
KWQK061353
May 27, 2013Spinal 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
KWQK090415
Mar 8, 2013Genesys 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
KWQK111132
Feb 4, 2013Synthes 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
KWQK050451
K051665 +1
Feb 4, 2013Synthes 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
KWQK050451
K051665 +1
Oct 10, 2012Medtronic 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
KWQK021461
K063100 +1
Oct 10, 2012Medtronic 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
KWQK021461
K063100 +1
Oct 10, 2012Medtronic 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
KWQK021461
K063100 +1
Aug 27, 2012Alphatec 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
KWQK102820
May 23, 2012Captiva 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
KWQK073708
May 23, 2012Captiva 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
KWQK073708
May 14, 2012Captiva 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
KWQK073708
Apr 25, 2012Aesculap 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
KWQK100243
Jan 11, 2012Medtronic 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
KWQK042025
Jan 11, 2012Medtronic 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
KWQK042025
May 13, 2011Integra 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
KWQK080690
Dec 10, 2010Zimmer Inc.
Spinal Concepts snap-fix polyaxial screwdriver, Manufactured by Spinal Concepts, Austin, TX, REF 781-3.
Terminated
KWQK031985
K052247 +2
Dec 10, 2010Zimmer Inc.
Spinal Concepts polyaxial screwdriver II, Manufactured by Spinal Concepts, Austin, TX, REF 781-2.
Terminated
KWQK031985
K052247 +2
Dec 10, 2010Zimmer Inc.
Spinal Concepts polyaxial screw driver, Manufactured by Spinal Concepts, Austin, TX, REF 781-01.
Terminated
KWQK031985
K052247 +2
Dec 10, 2010Zimmer Inc.
Spinal Concepts polyaxial screw driver, AO, Manufactured by Spinal Concepts, Austin, TX, REF 775-01.
Terminated
KWQK031985
K052247 +2
Oct 19, 2010Theken 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
KWQK080690
Jun 2, 2010Alphatec 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
KWQK070681
May 26, 2010Blackstone Medical, Inc.
Blackstone Medical Inc./ Orthofix Spinal Implants, Hallmark Anterior Cervical Plate System; Plate Bender Part number 62-0070. Non Sterile.
Terminated
KWQK050892
Apr 12, 2010Stryker 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
KWQK062310
Apr 12, 2010Stryker 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
KWQK062310
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 67MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 64MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 61MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 58MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 55MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 52MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 49MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 46MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 43MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 40MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 37MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 34MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 31MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 28MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 25MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 22MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 67MM, spinal implant component
Terminated
KWQK073437
Nov 24, 2009Stryker Spine
Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 64MM, spinal implant component
Terminated
KWQK073437

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