implaFit® hip stem cementless lateralized

FDA UDI

Class II (US FDA UDI)

by implantcast GmbH

Identity

Trade Name: implaFit® hip stem cementless lateralized FDA UDI
Generic Name: Coated femoral stem prosthesis, one-piece FDA UDI
Model / Reference: 80020002 FDA UDI

Identifiers

Primary DI / UDI-DI: 04048844477219 FDA UDI
FDA Product Code: LZO FDA UDI
KWY FDA UDI
GMDN Term: Coated femoral stem prosthesis, one-piece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3390 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Coated femoral stem prosthesis, one-piece

implaFit® hip stem cementless lateralized by implantcast GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: implantcast GmbH

Sources (1)

FDA UDI 95f7e5dd-d64b-495a-908a-f9fcd4e4d9e7 33 fields · synced May 31, 2026