REVISION Hip

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name: REVISION Hip FDA UDI
Generic Name: Femoral stem prosthesis trial FDA UDI
Device Name: Trial Stem Dia. 17 mm, L 140 mm FDA UDI
Model / Reference: Trial Stem FDA UDI
Description: Trial Stem Dia. 17 mm, L 140 mm FDA UDI

Identifiers

Catalog Number: 9038.13.410 FDA UDI
Primary DI / UDI-DI: 08033390115094 FDA UDI
510(k) Number: K161226 FDA UDI
FDA Product Code: LPH FDA UDI
LZO FDA UDI
KWY FDA UDI
GMDN Term: Femoral stem prosthesis trial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3358 FDA UDI
888.3353 FDA UDI
888.3390 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Femoral stem prosthesis trial

REVISION Hip by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K161226 also covers:

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: Limacorporate

Sources (1)

FDA UDI 228c277c-3cac-490e-b35e-9f44e437ed3c 36 fields · synced Jun 8, 2026