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)
Top companies in KWP
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 54 | 12 |
| Synthes (Usa) | 17 | 0 |
| Zimmer, Inc. | 7 | 10 |
| Danek Medical, Inc. | 16 | 0 |
| K2m | 12 | 3 |
| Acromed Corp. | 14 | 0 |
| Seaspine, Inc. | 3 | 10 |
| Sofamor Danek USA,Inc. | 13 | 0 |
| Depuy, Inc. | 11 | 0 |
| Alphatec Spine, Inc. | 4 | 6 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2023 | Medtronic 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 |
KWP | K163375 |
| Apr 19, 2023 | Medtronic 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 |
KWP | K163375 |
| Apr 19, 2023 | Medtronic 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 |
KWP | K163375 |
| Apr 19, 2023 | Medtronic 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 |
KWP | K163375 |
| Apr 19, 2023 | Medtronic 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 |
KWP | K163375 |
| 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 |
| Mar 26, 2020 | Medtronic Sofamor Danek USA Inc VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628 Terminated |
KWP | K081297 |
| Jan 28, 2020 | Medicrea International Iliac Screws, multiple sizes,
Article Nos. B36020500
B36020570
B36020580
B36020590
B36027500
B36027570
B36027580
B36027590
B36028500
B36028570
B36028580
B36028590
B36029500
B36029570
B36029580
B36029 Terminated |
KWP | K190376 |
| Jan 28, 2020 | Medicrea International Pedicle Screws, multiple sizes,
Article Nos. B36004525
B36004530
B36004535
B36004540
B36004545
B36004550
B36004555
B36005530
B36005535
B36005540
B36005545
B36005550
B36005555
B36005560
B36006530
B360 Terminated |
KWP | K190376 |
| Dec 31, 2019 | ulrich medical USA Inc Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw Terminated |
KWP | K150650 |
| Sep 16, 2019 | Medicrea International Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol
Product reference: A06010140 Open, Classified |
KWP | K190376 |
| Sep 16, 2019 | Medicrea International Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol
Product reference : A06010130 Open, Classified |
KWP | K190376 |
| Feb 22, 2019 | Zimmer 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 |
KWP | K171907 |
| Nov 14, 2018 | Zimmer 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 |
KWP | K151224 |
| Jan 13, 2017 | Medacta 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 |
KWP | K121115 |
| Oct 20, 2016 | RTI 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 |
KWP | K150254 |
| May 26, 2016 | Biomet, Inc. Various trauma and sports medicine instruments and implants.
Spinal interlaminal fixation orthosis. Terminated |
KWP | K083071 |
| May 26, 2016 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument. Terminated |
KWP | K150254 |
| Mar 18, 2016 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) RTI Surgical Streamline Occipito-Cervico-Thoracic (OCT) Final Driver, Common Name: Screw Driver Terminated |
KWP | K150254 |
| Feb 3, 2016 | Zimmer Spine, Inc. Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3). Terminated |
KWP | K133556 |
| Nov 17, 2015 | Zimmer 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 |
KWP | K133556 |
| Sep 10, 2015 | Biomet 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 |
KWP | K122378 |
| Dec 12, 2014 | Zimmer, 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 |
KWP | K041808 |
| Sep 3, 2014 | PIONEER SURGICAL TECHNOLOGY, INC. STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW
REF 26-SETSCREW
NON-STERILE, SINGLE USE, RX ONLY Terminated |
KWP | K112757 |
| Jan 28, 2014 | Orthofix, 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 |
KWP | K081684 |
| Aug 22, 2013 | Stryker 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 |
KWP | K093670 |
| Mar 18, 2013 | Alphatec 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 |
KWP | K042673 |
| Feb 28, 2013 | Orthofix, 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 |
KWP | K080407 |
| Nov 21, 2012 | SpineFrontier, 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 |
KWP | K093438 |
| Nov 8, 2012 | Alphatec 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 |
KWP | K033090 |
| Jan 31, 2012 | Alphatec 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 |
KWP | K052201 K071380 |
| Aug 19, 2011 | Medtronic 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 |
KWP | K984522 |
| Jul 25, 2011 | Medtronic 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 |
KWP | K042025 |
| Jul 25, 2011 | Medtronic 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 |
KWP | K042498 |
| Jul 25, 2011 | Medtronic 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 |
KWP | K042025 |
| Jul 25, 2011 | Medtronic 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 |
KWP | K031655 |
| Oct 8, 2010 | Zimmer Inc. SpeedLink 6.0 Transverse Connector X-Long 60-75mm, non-sterile, 1304-60XL Terminated |
KWP | K002082 |
| Oct 8, 2010 | Zimmer Inc. SpeedLink 6.0 Transverse Connector Long 50-60mm, non-sterile, 1304-60L Terminated |
KWP | K002082 |
| Oct 8, 2010 | Zimmer Inc. SpeedLink 6.0 Transverse Connector Medium 43-51mm, non-sterile, 1304-60M Terminated |
KWP | None listed |
| Oct 8, 2010 | Zimmer Inc. SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S Terminated |
KWP | K002082 |
| Oct 8, 2010 | Zimmer Inc. SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL Terminated |
KWP | K002082 |
| Oct 8, 2010 | Zimmer Inc. SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L Terminated |
KWP | K002082 |
| Oct 8, 2010 | Zimmer Inc. SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M Terminated |
KWP | K002082 |
| Oct 8, 2010 | Zimmer Inc. SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S Terminated |
KWP | K002082 |
| Dec 14, 2009 | Zimmer 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 |
KWP | K002082 |
| Dec 14, 2009 | Alphatec Spine, Inc. Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14 Terminated |
KWP | K052201 K071380 |
| Dec 14, 2009 | Alphatec Spine, Inc. Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12 Terminated |
KWP | K052201 K071380 |
| Dec 7, 2009 | Alphatec 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 |
KWP | K042673 |
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