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Asphere 1365-53-100

by Depuy (Ireland)

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 Number10603295033967 UDI-DI Date24 Mar 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  • Withdrawn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
Asphere
Generic Name
Metallic femoral head prosthesis
Model / Ref / Catalog
1365-53-100, 136553100
Primary DI / UDI-DI
10603295033967
510(k) Number
FDA Product Code
KWA, JDI, LPH
GMDN Term
Metallic femoral head prosthesis
Device Class
Class III
Regulation Number
888.3330, 888.3350, 888.3358
GUDID distribution status
In Commercial Distribution

Related devices

Category: Metallic femoral head prosthesis

Cleared under the same submission (K082585)

Show all (12)

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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