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Bio-Anchor C6121H

by Conmed Corporation

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20845854030797 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1548-05 FDA Unclassified (pre-2012) initiated 22 Feb 2005 on shared 510(k) K042778

    Linvatec has determined there is a possibility the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec. Therefore there is a potential for compromised sterility of the devices.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Bio-Anchor
Generic Name
Tendon/ligament bone anchor, non-bioabsorbable
Model / Ref / Catalog
C6121H
Primary DI / UDI-DI
20845854030797
510(k) Number
FDA Product Code
HWC
GMDN Term
Tendon/ligament bone anchor, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
Not in Commercial Distribution
Size
Length — 10.5 Millimeter
Outer Diameter — 3.5 Millimeter

Other devices from Conmed Corporation

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No