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510(k) K142079

STALIF CTI, STALIF C by Centinel Spine, Inc. — Product Code OVE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2014
Date Received
July 31, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.

Other clearances by Centinel Spine, Inc.

  • K250554 — prodisc® L Instruments (April 25, 2025)
  • K242869 — prodisc® L Instruments (December 17, 2024)
  • K221848 — prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (August 19, 2022)
  • K173347 — STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF (May 8, 2018)
  • K152211 — PCT System (December 1, 2015)
  • K150053 — STALIF C; STALIF C-Ti (June 24, 2015)
  • K150643 — Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti (June 8, 2015)
  • K141942 — MIDLINE II TI (November 7, 2014)
  • K133200 — STALIF C(R) (May 8, 2014)
  • K133286 — MIDLINE (TM) (January 9, 2014)

Other clearances for product code OVE

  • K260038 — E3D™-C Interbody System (February 4, 2026)
  • K253876 — HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) (December 22, 2025)
  • K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) (December 11, 2025)
  • K250076 — Endeavor™ Stand-Alone Cervical IBF System (September 25, 2025)
  • K250540 — SABER-C System (August 8, 2025)
  • K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs) (July 30, 2025)
  • K251431 — FIX-C PEEK ACIF SA System (June 27, 2025)
  • K251117 — Cervical Spine Truss System (CSTS) (April 25, 2025)
  • K242928 — Tesera-k SC System (April 10, 2025)
  • K243188 — CYLOX® ST (February 11, 2025)