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Posterior Cervical Screw System
FDA product code NKG · Class 2 · Orthopedic
23,433
Registered devices
2,233
Adverse events
6
Recalls
119
510(k) clearances
Devices with this code
PCT — Centinel Spine, LLCPCT — Centinel Spine, LLCVuePoint — Nuvasive, Inc.BRIDALVEIL — Astura MedicalYUKON OCT Spinal System — VB Spine LLCProficient™ Posterior Cervical Spine System — Spine Wave, Inc.Proficient® Posterior Cervical Spine System — Spine Wave, Inc.PCT — Centinel Spine, LLCASTRA-OCT Spine System — SPINECRAFT, LLCOverwatch PCF — SPINAL ELEMENTS, INC.Sochi — Altus Spine, LLCReLine — Nuvasive, Inc.Sochi — Altus Spine, LLCUNiD_PASS — MEDICREA INTERNATIONALQUARTEX — GLOBUS MEDICAL, INC.Proficient™ Posterior Cervical Spine System — Spine Wave, Inc.CastleLoc-S Posterior Cervical Fixation System/LnK Posterior Cervical Fixation S — L&K BIOMED CO. ,LTD.YUKON OCT Spinal System — VB Spine LLCINFINITY™ Occipitocervical Upper Thoracic System — MEDTRONIC SOFAMOR DANEK, INC.INFINITY™ Occipitocervical Upper Thoracic System — MEDTRONIC SOFAMOR DANEK, INC.Medyssey Poseidon OCT Spinal Fixation System — Medyssey Co., Ltd.Medyssey Poseidon OCT Spinal Fixation System — Medyssey Co., Ltd.Invictus — ALPHATEC SPINE, INC.ASTRA-OCT Spine System — SPINECRAFT, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-12-14 | K2M, Inc | The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length). |
| 2020-11-03 | K2M, Inc | Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay |
| 2019-09-16 | Synthes (USA) Products LLC | The subject product measures 4.0mm in diameter instead of 3.5mm. |
| 2018-07-24 | K2M, Inc | Screws had a manufacturing error that could prevent the screw from mating with the screw inserter or set screw as intended. This event was reported to FDA as pa |
| 2018-02-23 | Orthofix, Inc | Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: |
| 2018-02-23 | Orthofix, Inc | Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: |
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