Adapter Sleeve

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: Adapter Sleeve FDA UDI
Generic Name: Femoral head/stem prosthesis adaptor FDA UDI
Device Name: Morse/C-Taper FDA UDI
Model / Reference: 1034-0000J FDA UDI
Description: Morse/C-Taper FDA UDI

Identifiers

Catalog Number: 1034-0000J FDA UDI
Primary DI / UDI-DI: 04546540169457 FDA UDI
510(k) Number: K885102 FDA UDI
FDA Product Code: LZO FDA UDI
GMDN Term: Femoral head/stem prosthesis adaptor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 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

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

Category: Femoral head/stem prosthesis adaptor

Adapter Sleeve by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Femoral head/stem prosthesis adaptor.

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BIOLOX OPTION HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Solitude Unipolar — ORTHO DEVELOPMENT CORP. · Class II
CONSERVE® — MicroPort Orthopedics Inc. · Class II
PROFEMUR® — MicroPort Orthopedics Inc. · Class II
BIO-MOORE ENDO II HIP SYSTEM — Biomet Orthopedics, Inc. · Class II

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: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 652e4b21-5fdf-4fb1-984c-6261badaf37c 35 fields · synced May 30, 2026