REVISION Hip

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name: REVISION Hip FDA UDI
Generic Name: Orthopaedic implant impactor, reusable FDA UDI
Device Name: Dynamic Impactor FDA UDI
Model / Reference: Dynamic Impactor FDA UDI
Description: Dynamic Impactor FDA UDI

Identifiers

Catalog Number: 9038.10.300 FDA UDI
Primary DI / UDI-DI: 08033390112611 FDA UDI
510(k) Number: K151739 FDA UDI
FDA Product Code: KWY FDA UDI
LZO FDA UDI
LPH FDA UDI
GMDN Term: Orthopaedic implant impactor, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3390 FDA UDI
888.3353 FDA UDI
888.3358 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: Orthopaedic implant impactor, reusable

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

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Also classified as Orthopaedic implant impactor, reusable.

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Cleared under the same submission

K151739 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 90cf1dbd-7b19-4b59-b156-70d67427d369 35 fields · synced May 31, 2026