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REVISION Hip

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name
REVISION Hip FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
Neck Impactor Extractor FDA UDI
Model / Reference
Neck Impactor Extractor FDA UDI
Description
Neck Impactor Extractor FDA UDI

Identifiers

Catalog Number
9038.10.630 FDA UDI
Primary DI / UDI-DI
08033390112642 FDA UDI
510(k) Number
K151739 FDA UDI
FDA Product Code
LPH FDA UDI
KWY FDA UDI
LZO FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic inorganic implant inserter/extractor, reusable

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

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.

Cleared under the same submission

K151739 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Limacorporate

Sources (1)

  • FDA UDI e5372fd9-fb77-4dd5-b6e3-df7ca1ceba2c 35 fields · synced May 31, 2026