PCT System
FDA 510(k) K152211 · Centinel Spine, Inc.
510(k) numberK152211
Submission
- Device name
- PCT System
- Applicant
- Centinel Spine, Inc.
West Chester, PA, US - Received
- August 7, 2015
- Decision date
- December 1, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NKG – Posterior Cervical Screw System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3075
- Specialty
- Orthopedic
- Implant
- Yes
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…
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| K253195 | TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsNKG · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 06/02/2026SE |
| K254045 | CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…NKG · Traditional | CarboFix Orthopedics , Ltd. | 03/16/2026SE |
| K254165 | Infinity OCT SystemNKG · Special | Medtronic Sofamor Danek USA, Inc. | 01/21/2026SE |
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| K253129 | Infinity OCT SystemNKG · Special | Medtronic Sofamor Danek USA, Inc. | 10/24/2025SE |
| K251725 | ANAX OCT Spinal SystemNKG · Special | Cg Medtech Co., Ltd. | 06/25/2025SE |
| K250866 | Sovereign Posterior Cervical SystemNKG · Traditional | Met One Technologies, LLC | 05/20/2025SE |
| K242674 | Freedom Posterior Cervical ScrewsNKG · Traditional | Signature Orthopaedics Pty, Ltd. | 05/13/2025SE |
| K250332 | Virage® OCT Spinal Fixation SystemNKG · Traditional | Highridge Medical, LLC | 04/04/2025SE |
| K242516 | EUROPA Posterior Cervical Fusion SystemNKG · Traditional | MiRus, LLC | 11/19/2024SE |
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| K173347 | STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX…MAX · Traditional | 05/08/2018SE |
| K150053 | STALIF C; STALIF C-TiOVE · Traditional | 06/24/2015SE |
| K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiOVD · Traditional | 06/08/2015SE |
| K141942 | Midline II TiOVD · Traditional | 11/07/2014SE |
| K142079 | Stalif Cti, Stalif COVE · Traditional | 10/24/2014SE |
| K133200 | Stalif C(R)OVE · Traditional | 05/08/2014SE |
| K133286 | Midline (TM)OVD · Special | 01/09/2014SE |
Questions and answers
When was PCT System cleared by the FDA?
PCT System (K152211) received a 510(k) decision of Substantially Equivalent on December 1, 2015, 116 days after the submission was received.
What is the product code of K152211?
The FDA product code is NKG – Posterior Cervical Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3075.