Identity™

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: Identity™ FDA UDI
Generic Name: Orthopaedic broach FDA UDI
Model / Reference: SBHS0718 FDA UDI

Identifiers

Catalog Number: SBHS0718 FDA UDI
Primary DI / UDI-DI: 00889024628991 FDA UDI
510(k) Number: K213856 FDA UDI
FDA Product Code: MBF FDA UDI
PHX FDA UDI
KWT FDA UDI
KWS FDA UDI
HSD FDA UDI
GMDN Term: Orthopaedic broach FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3670 FDA UDI
888.3660 FDA UDI
888.3650 FDA UDI
888.3690 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic broach

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

Similar devices

Also classified as Orthopaedic broach.

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INSTRUMENT — Howmedica Osteonics Corp. · Class I
Equinoxe — Exactech, Inc. · Class II
Anthology — Smith & Nephew, Inc. · Class I
Affinity J (Instruments for Microscope) — MEDTRONIC SOFAMOR DANEK, INC. · Class I
iNSitu™ Hip System — Nextstep Arthropedix · Class I
TEMA Elbow — Limacorporate · Class II

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 e29d34b9-b9a8-4e3e-9ba5-38b092f596c3 36 fields · synced Jun 8, 2026