REVISION Hip

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name: REVISION Hip FDA UDI
Generic Name: Medullary canal orthopaedic reamer, rigid FDA UDI
Device Name: Reamer Dia=23mm L=140mm FDA UDI
Model / Reference: Reamer FDA UDI
Description: Reamer Dia=23mm L=140mm FDA UDI

Identifiers

Catalog Number: 9038.10.065 FDA UDI
Primary DI / UDI-DI: 08033390050722 FDA UDI
510(k) Number: K151739 FDA UDI
FDA Product Code: KWY FDA UDI
LZO FDA UDI
LPH FDA UDI
GMDN Term: Medullary canal orthopaedic reamer, rigid 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: Medullary canal orthopaedic reamer, rigid

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

Similar devices

Also classified as Medullary canal orthopaedic reamer, rigid.

POLARSTEM — Smith & Nephew, Inc. · Class II
Intramedullary Reamer, Revision — TOTAL JOINT ORTHOPEDICS, INC. · Class I
INSTRUMENT — Howmedica Osteonics Corp. · Class I
Comprehensive® Shoulder Instruments — Biomet Orthopedics, Inc. · Class II
MP Reconstruction System - Instruments — WALDEMAR LINK GmbH & Co. KG · Class I
Panta® 2 — Ascension Orthopedics, Inc. · Class I
Legion — Smith & Nephew, Inc. · Class II
INSTRUMENT — Howmedica Osteonics Corp. · Class I

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 4045cbbe-e843-4cce-8222-81ebec49e0c2 36 fields · synced May 31, 2026