Alpine

FDA UDI

Class II (US FDA UDI)

by Ortho Development Corp.

Identity

Trade Name: Alpine FDA UDI
Generic Name: Metal-on-polyethylene total hip prosthesis FDA UDI
Device Name: Alpine Cemented Stem 11 STD FDA UDI
Model / Reference: 700-0211 FDA UDI
Description: Alpine Cemented Stem 11 STD FDA UDI

Identifiers

Primary DI / UDI-DI: 00822409000289 FDA UDI
510(k) Number: K153216 FDA UDI
FDA Product Code: MBL FDA UDI
LPH FDA UDI
JDI FDA UDI
KWL FDA UDI
LZO FDA UDI
KWY FDA UDI
GMDN Term: Metal-on-polyethylene total hip prosthesis FDA UDI

Classification

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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Metal-on-polyethylene total hip prosthesis

Alpine by Ortho Development Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metal-on-polyethylene total hip prosthesis.

Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
U2 Femoral head, Ø36mm, +0mm — UNITED ORTHOPEDIC CORP. · Class II
Libertas — MAXX ORTHOPEDICS INC. · Class II
Libertas — MAXX ORTHOPEDICS INC. · Class II
Cancellous Bone Screw with 6.5mm Head Diameter, 30mm — TOTAL JOINT ORTHOPEDICS, INC. · Class II
"UNITED" USTAR II Hip System — UNITED ORTHOPEDIC CORP. · Class II
Conformis Hip System — Conformis, Inc. · Class II
Initia Total Hip System — Kyocera Corporation · Class II

Cleared under the same submission

K153216 also covers:

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: Ortho Development Corp.

Sources (1)

FDA UDI e7fbe40f-30b9-4f0b-b226-d320b420c375 35 fields · synced May 30, 2026