ClearanceBrief
Panels › Orthopedic › Product code KWP · Class 2

Appliance, Fixation, Spinal Interlaminal

Regulation 888.3050

0510(k)s in 12 months (430 all time)
0recalls in 12 months (68 all time)
65recalls that name a 510(k)
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Top companies in KWP

DateFirm and productCodeLinked 510(k)
Apr 19, 2023Medtronic Sofamor Danek USA Inc
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following a
Open, Classified
KWPK163375
Apr 19, 2023Medtronic Sofamor Danek USA Inc
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following a
Open, Classified
KWPK163375
Apr 19, 2023Medtronic Sofamor Danek USA Inc
INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; for immobilization and stabilization of spinal segment as an adjunct to fusio
Open, Classified
KWPK163375
Apr 19, 2023Medtronic Sofamor Danek USA Inc
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following a
Open, Classified
KWPK163375
Apr 19, 2023Medtronic Sofamor Danek USA Inc
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following a
Open, Classified
KWPK163375
Jun 13, 2022K2M, Inc.
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Open, Classified
KWPK171444
Jan 13, 2022K2M, Inc
Everest MI XT Outer Dilator, Catalog Number 5101-90168
Open, Classified
KWPNone listed
Jan 13, 2022K2M, Inc
Everest MI XT Inner Dilator, Catalog Number 5101-90167
Open, Classified
KWPNone listed
Mar 26, 2020Medtronic Sofamor Danek USA Inc
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Terminated
KWPK081297
Jan 28, 2020Medicrea International
Iliac Screws, multiple sizes, Article Nos. B36020500 B36020570 B36020580 B36020590 B36027500 B36027570 B36027580 B36027590 B36028500 B36028570 B36028580 B36028590 B36029500 B36029570 B36029580 B36029
Terminated
KWPK190376
Jan 28, 2020Medicrea International
Pedicle Screws, multiple sizes, Article Nos. B36004525 B36004530 B36004535 B36004540 B36004545 B36004550 B36004555 B36005530 B36005535 B36005540 B36005545 B36005550 B36005555 B36005560 B36006530 B360
Terminated
KWPK190376
Dec 31, 2019ulrich medical USA Inc
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Terminated
KWPK150650
Sep 16, 2019Medicrea International
Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
Open, Classified
KWPK190376
Sep 16, 2019Medicrea International
Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
Open, Classified
KWPK190376
Feb 22, 2019Zimmer Biomet Spine Inc.
Vitality Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Ort
Terminated
KWPK171907
Nov 14, 2018Zimmer Biomet, Inc.
Lineum 4.35mm x 28mm Translation Screw, Model No. 14-524728 The Lineum OCT Spine System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute an
Terminated
KWPK151224
Jan 13, 2017Medacta Usa Inc
Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable cons
Terminated
KWPK121115
Oct 20, 2016RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage: When intended to promote fusion of the cervical spine and occipitocervico-thoracic junctio
Terminated
KWPK150254
May 26, 2016Biomet, Inc.
Various trauma and sports medicine instruments and implants. Spinal interlaminal fixation orthosis.
Terminated
KWPK083071
May 26, 2016RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
Terminated
KWPK150254
Mar 18, 2016RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver
Terminated
KWPK150254
Feb 3, 2016Zimmer Spine, Inc.
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Terminated
KWPK133556
Nov 17, 2015Zimmer Biomet, Inc.
Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Numb
Terminated
KWPK133556
Sep 10, 2015Biomet Spine, LLC
Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum syste
Terminated
KWPK122378
Dec 12, 2014Zimmer, Inc.
Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endius TITLE 2 Polyaxial Spinal System, used for posterior lumbar fus
Terminated
KWPK041808
Sep 3, 2014PIONEER SURGICAL TECHNOLOGY, INC.
STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
Terminated
KWPK112757
Jan 28, 2014Orthofix, Inc.
Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver, Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal f
Terminated
KWPK081684
Aug 22, 2013Stryker Spine
Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long 5) Mini. Allows for positioning directly on the midline keel of the occiput.
Terminated
KWPK093670
Mar 18, 2013Alphatec Spine, Inc.
ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO MIS Posterior Spinal Fixation System is intended to facilitate the surgical co
Terminated
KWPK042673
Feb 28, 2013Orthofix, Inc
Firebird Spinal Fixation System, Parallel Rod Connector (52-6800) and Axial Rod Connector (52-6700). Product Usage: The connector assemblies allow for rod components to be connected side-to-side, o
Terminated
KWPK080407
Nov 21, 2012SpineFrontier, Inc.
Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan implants into the spinous process bone, resulting in fixation of the implant.
Terminated
KWPK093438
Nov 8, 2012Alphatec Spine, Inc.
TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation
Terminated
KWPK033090
Jan 31, 2012Alphatec Spine, Inc.
Solanas Posterior Stabilization System Part Number: 63920. Solanas Posterior Stabilization System facilitates the surgical correction of spinal deformities by providing temporary internal fixation an
Terminated
KWPK052201
K071380
Aug 19, 2011Medtronic Sofamor Danek USA Inc
TSRH(R) Spinal System SCREW, REF 837-645, Size: 6.5mm x 45mm, Mat'l: TITANIUM ALLOY, Rx only, QTY: 1 EA, Medtronic Sofamor Danek USA. Product Usage: TSRH(R) Spinal System is intended to help prov
Terminated
KWPK984522
Jul 25, 2011Medtronic Sofamor Danek USA Inc
ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilization of spinal segmen
Terminated
KWPK042025
Jul 25, 2011Medtronic Sofamor Danek USA Inc
VERTEX (R), REF 69004440, cortical screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilization of spinal segments as
Terminated
KWPK042498
Jul 25, 2011Medtronic Sofamor Danek USA Inc
CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilization of
Terminated
KWPK042025
Jul 25, 2011Medtronic Sofamor Danek USA Inc
CD HORIZON (R) LEGACY (TM) FAS, REF 7542535, pedicle screw, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 Intended to help provide immobilization and stabilization of s
Terminated
KWPK031655
Oct 8, 2010Zimmer Inc.
SpeedLink 6.0 Transverse Connector X-Long 60-75mm, non-sterile, 1304-60XL
Terminated
KWPK002082
Oct 8, 2010Zimmer Inc.
SpeedLink 6.0 Transverse Connector Long 50-60mm, non-sterile, 1304-60L
Terminated
KWPK002082
Oct 8, 2010Zimmer Inc.
SpeedLink 6.0 Transverse Connector Medium 43-51mm, non-sterile, 1304-60M
Terminated
KWPNone listed
Oct 8, 2010Zimmer Inc.
SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S
Terminated
KWPK002082
Oct 8, 2010Zimmer Inc.
SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Terminated
KWPK002082
Oct 8, 2010Zimmer Inc.
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Terminated
KWPK002082
Oct 8, 2010Zimmer Inc.
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Terminated
KWPK002082
Oct 8, 2010Zimmer Inc.
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Terminated
KWPK002082
Dec 14, 2009Zimmer Inc.
Abbott Spine Thoracolumbar Common, SpdLnk 5.5 Trans Cntr Med 43-51 mm, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1302-55M. Note: This lot was not distributed in the United St
Terminated
KWPK002082
Dec 14, 2009Alphatec Spine, Inc.
Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14
Terminated
KWPK052201
K071380
Dec 14, 2009Alphatec Spine, Inc.
Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12
Terminated
KWPK052201
K071380
Dec 7, 2009Alphatec Spine, Inc.
Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a p
Terminated
KWPK042673

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