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Bi-Angular / Bi-Polar Shoulder

FDA UDI

Class III (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
BI-ANGULAR / BI-POLAR SHOULDER FDA UDI
Generic Name
Bipolar partial shoulder prosthesis FDA UDI
Model / Reference
113142 FDA UDI

Identifiers

Catalog Number
113142 FDA UDI
Primary DI / UDI-DI
00880304001619 FDA UDI
510(k) Number
K960363 FDA UDI
FDA Product Code
MJT FDA UDI
KWT FDA UDI
GMDN Term
Bipolar partial shoulder prosthesis FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
888.3650 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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Bipolar partial shoulder prosthesis

Bi-Angular / Bi-Polar Shoulder by Biomet Orthopedics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bipolar partial shoulder prosthesis.

Cleared under the same submission

K960363 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biomet Orthopedics, Inc.

Sources (1)

  • FDA UDI 63456bbf-ba98-4816-861f-ef9132484f7b 36 fields · synced May 30, 2026