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Identity™

FDA UDIEUDAMED

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name
Identity™ FDA UDI
Generic Name
Shoulder reverse/standard adaptor prosthesis FDA UDI
Model / Reference
SAHAF135 FDA UDI

Identifiers

Catalog Number
SAHAF135 FDA UDI
Primary DI / UDI-DI
00889024626492 FDA UDI
510(k) Number
K213856 FDA UDI
FDA Product Code
MBF FDA UDI
HSD FDA UDI
KWS FDA UDI
KWT FDA UDI
PHX FDA UDI
GMDN Term
Shoulder reverse/standard adaptor prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3670 FDA UDI
888.3690 FDA UDI
888.3660 FDA UDI
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
MRI Safety
MR Conditional FDA UDI

Category: Shoulder reverse/standard adaptor prosthesis

Identity™ by Zimmer, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Shoulder reverse/standard adaptor prosthesis.

Cleared under the same submission

K213856 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zimmer, Inc.

Sources (2)

  • FDA UDI 3fd7ad61-361c-42c8-9f6a-b8d223857951 36 fields · synced Jun 18, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026