Identity™

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: Identity™ FDA UDI
Generic Name: Stem-fixed metallic humeral head prosthesis FDA UDI
Model / Reference: SAHH4218T FDA UDI

Identifiers

Catalog Number: SAHH4218T FDA UDI
Primary DI / UDI-DI: 00889024626669 FDA UDI
510(k) Number: K213856 FDA UDI
FDA Product Code: MBF FDA UDI
KWT FDA UDI
PHX FDA UDI
HSD FDA UDI
KWS FDA UDI
GMDN Term: Stem-fixed metallic humeral head prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3670 FDA UDI
888.3650 FDA UDI
888.3660 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Stem-fixed metallic humeral head prosthesis

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

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Cleared under the same submission

K213856 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Zimmer, Inc.

Sources (1)

FDA UDI eed4915a-b6d7-4686-8fa1-70f5160ac7bd 36 fields · synced May 30, 2026