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: Modular Hip System FDA UDI
Model / Reference: 6276-6-021 FDA UDI
Description: Modular Hip System FDA UDI

Identifiers

Catalog Number: 6276-6-021 FDA UDI
Primary DI / UDI-DI: 04546540642868 FDA UDI
FDA Product Code: MBL FDA UDI
LPH FDA UDI
LWJ FDA UDI
MEH FDA UDI
MAY FDA UDI
KWY FDA UDI
JDI FDA UDI
LZO FDA UDI
KWZ FDA UDI
KWL FDA UDI
GMDN Term: Press-fit femoral stem prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3358 FDA UDI
888.3360 FDA UDI
888.3353 FDA UDI
888.3390 FDA UDI
888.3350 FDA UDI
888.3310 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

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Howmedica Osteonics Corp.

Sources (1)

FDA UDI 3c16e5d5-eb71-4ed7-8a97-70692f9b006b 35 fields · synced May 30, 2026