implaFit® hip stem cementless standard 80030006

by implantcast GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04048844477158 UDI-DI	Date19 Aug 2022Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: implaFit® hip stem cementless standard
Generic Name: Coated femoral stem prosthesis, one-piece
Model / Reference: 80030006

Primary DI / UDI-DI: 04048844477158
510(k) Number: K210678
FDA Product Code: LZO, KWY
GMDN Term: Coated femoral stem prosthesis, one-piece

Device Class: Class II
Regulation Number: 888.3353, 888.3390
GUDID distribution status: In Commercial Distribution

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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