# Centinel Spine, Inc.

- Location (FDA's records): West Chester, PA
- FDA decisions: 17 (2006–2026): 15 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: Centinel Spine, Inc. (10); Centinel Spine, LLC (6); Centinel Spine (1)
- Product codes: OVE (4), OVD (4), QLQ (4), MJO (2), MAX (2), NKG (1)
- Predicates its devices cite: 41 (14 its own); citations of its devices by later devices: 62 (14 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Surgicraft, Ltd.: 6 (https://510kreport.com/company/surgicraft)
- Medtronic Sofamor Danek USA, Inc.: 2 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- Theken Spine, LLC: 2 (https://510kreport.com/company/theken-spine)
- Eisertech, LLC: 2 (https://510kreport.com/company/eisertech)
- Pinnacle Spine Group, LLC: 2 (https://510kreport.com/company/pinnacle-spine-group)
- Stryker Spine: 1 (https://510kreport.com/company/stryker-spine)
- Spinal Elements, Inc.: 1 (https://510kreport.com/company/spinal-elements)
- Aesculap Implant Systems, LLC: 1 (https://510kreport.com/company/aesculap-implant-systems)

## Firms that cite its devices most
- Spineart: 4 (https://510kreport.com/company/spineart)
- Nexus Spine, LLC: 4 (https://510kreport.com/company/nexus-spine)
- Globus Medical, Inc.: 3 (https://510kreport.com/company/globus-medical)
- Providence Medical Technology, Inc.: 3 (https://510kreport.com/company/providence-medical-technology)
- Nu Vasive, Incorporated: 2 (https://510kreport.com/company/nu-vasive)
- Ldr Spine USA: 2 (https://510kreport.com/company/ldr-spine-usa)
- Neurostructures, Inc.: 2 (https://510kreport.com/company/neurostructures)
- Medacta International S.A.: 2 (https://510kreport.com/company/medacta-international)

## Its most-cited devices
- K120819: Stalif C (2012), cited by 11
- K150643: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti (2015), cited by 11
- K150053: STALIF C; STALIF C-Ti (2015), cited by 9
- K101301: Stalif Midline (2010), cited by 9
- K142079: Stalif Cti, Stalif C (2014), cited by 5
- K173347: STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX (2018), cited by 5

## Recent decisions
- K263159: prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments (Oct 7, 2026)
- K250554: prodisc® L Instruments (Apr 25, 2025)
- K242869: prodisc® L Instruments (Dec 17, 2024)
- K221848: prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (Aug 19, 2022)
- K173347: STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX (May 8, 2018)
- K152211: PCT System (Dec 1, 2015)
- K150053: STALIF C; STALIF C-Ti (Jun 24, 2015)
- K150643: Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti (Jun 8, 2015)

Source page: https://510kreport.com/company/centinel-spine