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Crossft Oc Suture Anchor Mode Cfc-4502, Cfc-5502, Cfc-6502, Cfc-4503, Cfc-5503, Cfc-6503

by Conmed Linvatec

510(k) K101100

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK101100 Date26 Aug 2010ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-3018-2026 FDA Class II initiated 14 Jul 2026

    Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.

    • Terminated Z-1619-2013 FDA Class II initiated 6 Mar 2013

    Incorrect blue/white suture was used.

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  • Withdrawn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
MAI
Device Class
Class II
Regulation
21 CFR Part 888.3030
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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