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ATOK Shoulder Anchor – Locking Plug 191-29-0002

by Signature Orthopaedics Pty Ltd

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number09348215164713 UDI-DI Date10 Oct 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ATOK Shoulder Anchor – Locking Plug
Generic Name
Tendon/ligament bone anchor, non-bioabsorbable
Model / Reference
191-29-0002
Primary DI / UDI-DI
09348215164713
510(k) Number
FDA Product Code
MBI
GMDN Term
Tendon/ligament bone anchor, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K242477)

Show all (12)

Other devices from Signature Orthopaedics Pty Ltd

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Properties

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

Other properties (7)

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