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Signature BiPolar Head 111-21-2848

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 Number09348215004019 UDI-DI Date28 Sep 2015ListedStatusListed 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  • Withdrawn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
Signature BiPolar Head
Generic name
Bipolar femoral head outer component, hemiarthroplasty
Model / reference
111-21-2848
Primary DI / UDI-DI
09348215004019
510(k) Number
FDA product code
KWY
GMDN term
Bipolar femoral head outer component, hemiarthroplasty
Device class
Class II
Regulation number
888.3390
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bipolar femoral head outer component, hemiarthroplasty

Cleared under the same submission (K133370)

Show all (12)

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date

Other properties (8)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No