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Posterior Cervical Screw System
FDA product code NKG · Class 2 · Orthopedic
22,801
Registered devices
2,190
Adverse events
6
Recalls
118
510(k) clearances
Devices with this code
PCT — Silony Medical CorpSAXXONY™ Posterior Cervical Thoracic System — NEXXT SPINE, LLCYUKON OCT Spinal System — VB Spine LLCPERLA ® — SpineArt SAInvictus — ALPHATEC SPINE, INC.INFINITY™ Occipitocervical Upper Thoracic System — MEDTRONIC SOFAMOR DANEK, INC.Reform POCT System — PRECISION SPINE, INC.PCT — Silony Medical CorpASTRA-OCT Spine System — SPINECRAFT, LLCASTRA-OCT Spine System — SPINECRAFT, LLCSYMPHONY — Medos International SàrlSYMPHONY — Medos International SàrlCENTURION — Orthofix US LLCCastleLoc-S Posterior Cervical Fixation System — L&K BIOMED CO. ,LTD.QUARTEX — GLOBUS MEDICAL, INC.QUARTEX — GLOBUS MEDICAL, INC.Medyssey Poseidon OCT Spinal Fixation System — Medyssey Co., Ltd.ELLIPSE — GLOBUS MEDICAL, INC.Certex Spinal Fixation System — Xtant Medical Holdings, Inc.VySpan™ — VY SPINE LLCneon³ CT spinal stabilization — Ulrich GmbH & Co. KGneon³ CT spinal stabilization — Ulrich GmbH & Co. KGSochi — Altus Spine, LLCBRIDALVEIL — Astura Medical
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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