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Revision

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name
REVISION FDA UDI
Generic Name
Revision coated hip femur prosthesis FDA UDI
Device Name
Neck with Screw H=60mm Taper 12/14 FDA UDI
Model / Reference
REVISION HIP - Ti6Al4V FDA UDI
Description
Neck with Screw H=60mm Taper 12/14 FDA UDI

Identifiers

Catalog Number
7515.15.010 FDA UDI
Primary DI / UDI-DI
08033390017749 FDA UDI
510(k) Number
K151739 FDA UDI
FDA Product Code
LZO FDA UDI
LPH FDA UDI
KWY FDA UDI
GMDN Term
Revision coated hip femur prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3353 FDA UDI
888.3358 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Revision coated hip femur prosthesis

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

Similar devices

Also classified as Revision coated hip femur prosthesis.

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 62ca4357-c260-47dc-a39f-312950447f33 36 fields · synced May 30, 2026