12/14 CoCr Femoral Head

FDA UDI

Class II (US FDA UDI)

by Ortho Development Corp.

Identity

Trade Name: 12/14 CoCr Femoral Head FDA UDI
Generic Name: Metal-on-polyethylene total hip prosthesis FDA UDI
Device Name: 40mm, +9mm FDA UDI
Model / Reference: 138-4009 FDA UDI
Description: 40mm, +9mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00822409016471 FDA UDI
510(k) Number: K042565 FDA UDI
FDA Product Code: MBL FDA UDI
LPH 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
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

Dimensions & Sizes

Size: Length — 9 Millimeter FDA UDI
Outer Diameter — 40 Millimeter FDA UDI

Category: Metal-on-polyethylene total hip prosthesis

12/14 CoCr Femoral Head 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

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: Ortho Development Corp.

Sources (1)

FDA UDI c6328caf-8204-4d2e-8197-c0f3e6b95180 36 fields · synced Jun 1, 2026