Chrysalis Intelligence · Product Codes · NKG

NKG · Posterior Cervical Screw System

Orthopedic · 50 clearances · 35 unique sponsors

Device class
Class II
Regulation 888.3075
Total clearances
50
2020-01-24 → 2026-06-02
Last 12 months
5
Unique sponsors
35
Definition

What is Posterior Cervical Screw System

Posterior cervical screw systems are intended for use in fusion procedures of the cervical spine and/or craniocervical junction and/or cervicothoracic junction for: 1) spinal fractures and dislocations; 2) deformities; 3) instabilities; 4) failed previous fusions; 5) tumors; 6) inflammatory disorders; 7) spinal degeneration, 8) facet degeneration with instability; and 9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to stabilize the spine in the absence of fusion for a limited time period in patients with tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
Medical specialty
Orthopedic
Review panel
OR
Regulation number
888.3075
Implant
Y
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Medos International SARL 4 0 2023-11-09
Medacta International S.A. 3 0 2022-04-26
Medtronic Sofamor Danek USA, Inc. 3 2 2026-01-21
Vy Spine, LLC 3 0 2023-09-27
Orthofix, Inc. 2 0 2021-07-30
L&K BIOMED Co., Ltd. 2 0 2023-07-20
Globus Medical, Inc. 2 0 2024-03-14
CarboFix Orthopedics , Ltd. 2 1 2026-03-16
Nu Vasive, Incorporated 2 0 2022-09-09
Alphatec Spine, Inc. 2 0 2020-12-18
Medtronic 1 0 2021-03-18
Ulrich Medical USA 1 0 2023-05-02
Signature Orthopaedics Pty, Ltd. 1 0 2025-05-13
MiRus, LLC 1 0 2024-11-19
Silony Medical GmbH 1 0 2020-04-07
ZheJiang Decans Medical Devices Co., Ltd. 1 1 2026-06-02
Spinal Simplicity, LLC 1 0 2023-07-10
Life Spine, Inc. 1 0 2020-04-28
Highridge Medical, LLC 1 0 2025-04-04
Double Medical Technology, Inc. 1 0 2023-11-22
SeaSpine Orthopedics Corporation 1 0 2020-03-25
Medicrea International 1 0 2022-04-19
Seaspine, Inc. 1 0 2023-08-03
Osseus Fusion Systems 1 0 2022-11-03
Zavation Medical Products, LLC 1 0 2021-08-11
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
22600 CPT High Arthrodesis, cervical; posterior (including instrumentation)
C1713 HCPCS Anchor/screw for opposing bone-to-bone or soft tissue-to-bone (implantable) ✓ CMS-verified description High Posterior cervical screw system for spinal fusion
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-02 K253195 ZheJiang Decans Medical Devices Co., Ltd. TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems
2026-03-16 K254045 CarboFix Orthopedics , Ltd. CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System
2026-01-21 K254165 Medtronic Sofamor Danek USA, Inc. Infinity™ OCT System
2025-11-12 K252327 Icotec AG CMORE® CT System; CMORE® CT System Navigated Instruments
2025-10-24 K253129 Medtronic Sofamor Danek USA, Inc. Infinity™ OCT System
2025-06-25 K251725 Cg Medtech Co., Ltd. ANAX™ OCT Spinal System
2025-05-20 K250866 Met One Technologies, LLC Sovereign Posterior Cervical System
2025-05-13 K242674 Signature Orthopaedics Pty, Ltd. Freedom Posterior Cervical Screws
2025-04-04 K250332 Highridge Medical, LLC Virage® OCT Spinal Fixation System
2024-11-19 K242516 MiRus, LLC EUROPA™ Posterior Cervical Fusion System
2024-03-27 K233989 CarboFix Orthopedics , Ltd. CarboClear® Posterior Cervical Screw System
2024-03-14 K231850 Globus Medical, Inc. QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments
2023-11-27 K233332 K&J Consulting Corp. Statera-C™ Spinal System
2023-11-22 K233078 Double Medical Technology, Inc. Posterior Cervical Spine System
2023-11-09 K233366 Medos International SARL SYMPHONY OCT System
2023-09-27 K232167 Vy Spine, LLC VySpan™ PCT System
2023-08-03 K231654 Seaspine, Inc. NorthStar OCT System
2023-07-20 K231840 L&K BIOMED Co., Ltd. CastleLoc-S Posterior Cervical Fixation System
2023-07-10 K221307 Spinal Simplicity, LLC Edge Upper Cervical System
2023-05-02 K230614 Ulrich Medical USA Cortium™
2023-02-24 K223852 Vy Spine, LLC VySpan™ PCT System
2023-01-11 K223764 Medtronic Sofamor Danek USA, Inc. INFINITY OCT System
2022-11-18 K220658 Signus Medizintechnik GmbH COSY Cervicothoracic Occipital Rod-Screw System
2022-11-03 K222107 Osseus Fusion Systems Black Diamond™ POCT Spinal System
2022-09-09 K221388 Nu Vasive, Incorporated NuVasive Reline Cervical System