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Anatomical Shoulder™ Glenoid

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name
Anatomical Shoulder™ Glenoid FDA UDI
Generic Name
Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
Device Name
A.S. Glenoid M cemented FDA UDI
Model / Reference
01.04214.370 FDA UDI
Description
A.S. Glenoid M cemented FDA UDI

Identifiers

Primary DI / UDI-DI
00889024285859 FDA UDI
510(k) Number
K990136 FDA UDI
FDA Product Code
KWT FDA UDI
KWS FDA UDI
GMDN Term
Shoulder glenoid fossa prosthesis, prefabricated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3650 FDA UDI
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

Yes

FDA UDI

Category: Shoulder glenoid fossa prosthesis, prefabricated

Anatomical Shoulder™ Glenoid by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Shoulder glenoid fossa prosthesis, prefabricated.

Cleared under the same submission

K990136 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zimmer, Inc.

Sources (1)

  • FDA UDI cc0b63ee-bb12-4eb6-83a2-b3a92a0bfbf6 36 fields · synced May 30, 2026