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Bio-Modular Reverse Shoulder

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name
BIO-MODULAR REVERSE SHOULDER FDA UDI
Generic Name
Reverse shoulder prosthesis body FDA UDI
Model / Reference
11-113680 FDA UDI

Identifiers

Catalog Number
11-113680 FDA UDI
Primary DI / UDI-DI
00880304591219 FDA UDI
510(k) Number
K093803 FDA UDI
FDA Product Code
KWS FDA UDI
GMDN Term
Reverse shoulder prosthesis body FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3660 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
MRI Safety
MR Conditional FDA UDI

Category: Reverse shoulder prosthesis body

Bio-Modular Reverse Shoulder by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Reverse shoulder prosthesis body.

Cleared under the same submission

K093803 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 bc312677-3b79-4677-8991-8f3340005e9c 36 fields · synced May 31, 2026