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Nano Suture Anchor

by Linvatec Corporation d/b/a ConMed Linvatec

510(k) K112965

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 closed

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 · Special NumberK112965 Date2 Nov 2011ClearedStatusActive

Recalls

6 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0066-2013 FDA Class II initiated 26 Jun 2012
    • Terminated Z-0068-2013 FDA Class II initiated 26 Jun 2012
    • Terminated Z-0067-2013 FDA Class II initiated 26 Jun 2012
    • Terminated Z-0064-2013 FDA Class II initiated 26 Jun 2012
    • Terminated Z-0063-2013 FDA Class II initiated 26 Jun 2012

    Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant.

    • Terminated Z-0065-2013 FDA Class II initiated 26 Jun 2012

    Linvatec Corporation DBA ConMed Linvatec in Largo, FL is recalling Press FT HI-FI Sutures (items NP 211, NP 212, NP 261, NP 262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant.

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  • Withdrawn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
MBI
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Linvatec Corporation d/b/a ConMed Linvatec