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Exactech Gibralt Spinal System

by Exactech, Inc.

510(k) K110197

Exactech Gibralt Spinal System is a Class II device made by Exactech, Inc., cleared under FDA 510(k) K110197 on 15 Jul 2011, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110197 Date15 Jul 2011ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1217-2014 FDA Class II initiated 6 Jan 2014

    The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy.

Timeline

2 dated events

  1. Cleared FDA 510(k) K110197
  2. Recall initiated FDA recalls Z-1217-2014

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MNI
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

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