Restoration

FDA UDI

Class II (US FDA UDI)

by Howmedica Osteonics Corp.

Identity

Trade Name: Restoration FDA UDI
Generic Name: Press-fit femoral stem prosthesis FDA UDI
Device Name: Hip Stem FDA UDI
Model / Reference: 6012-0812 FDA UDI
Description: Hip Stem FDA UDI

Identifiers

Catalog Number: 6012-0812 FDA UDI
Primary DI / UDI-DI: 07613327017748 FDA UDI
510(k) Number: K944836 FDA UDI
FDA Product Code: LZO FDA UDI
MEH FDA UDI
GMDN Term: Press-fit femoral stem prosthesis 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: Press-fit femoral stem prosthesis

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

Similar devices

Also classified as Press-fit femoral stem prosthesis.

Echo® Bi-Metric® Hip System — Biomet Orthopedics, Inc. · Class II
Novation — Exactech, Inc. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class III
OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
BI-METRIC X-SERIES HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
BI-METRIC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
Echo® Bi-Metric® Hip System — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

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 45f21570-39a3-4e53-9577-dc9bca7a8a65 36 fields · synced May 30, 2026