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Bio-Modular / Bi-Polar Shoulder

FDA UDI

Class III (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
BIO-MODULAR / BI-POLAR SHOULDER FDA UDI
Generic Name
Bipolar partial shoulder prosthesis FDA UDI
Model / Reference
113146 FDA UDI

Identifiers

Catalog Number
113146 FDA UDI
Primary DI / UDI-DI
00880304002388 FDA UDI
510(k) Number
K030710 FDA UDI
K960363 FDA UDI
FDA Product Code
MJT FDA UDI
KWT FDA UDI
KWS FDA UDI
MBF FDA UDI
HSD FDA UDI
GMDN Term
Bipolar partial shoulder prosthesis FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
888.3650 FDA UDI
888.3660 FDA UDI
888.3670 FDA UDI
888.3690 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

Bio-Modular / 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

K030710 also covers:

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 8df0f500-d423-41e5-af35-dd9bad1d4788 36 fields · synced Jun 1, 2026