VerSys®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: VerSys® FDA UDI
Generic Name: Metallic femoral head prosthesis FDA UDI
Model / Reference: 7818-44 FDA UDI

Identifiers

Catalog Number: 00-7818-044-00 FDA UDI
Primary DI / UDI-DI: 00889024135772 FDA UDI
510(k) Number: K955473 FDA UDI
FDA Product Code: LWJ FDA UDI
JDI FDA UDI
KWL FDA UDI
GMDN Term: Metallic femoral head prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3360 FDA UDI
888.3350 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

Category: Metallic femoral head prosthesis

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

Similar devices

Also classified as Metallic femoral head prosthesis.

Normmed CoCr Femoral Head 28 +12 — NORMMED MEDİKAL SAN. VE TİC. A.Ş. · Class III
Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
Orthinox — Howmedica Osteonics Corp. · Class II
Orthinox — Howmedica Osteonics Corp. · Class II
A110212031 — EUROS SAS · Class III
Consensus Hip System — SHALBY ADVANCED TECHNOLOGIES, INC. · Class II
BIOMET HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Femoral Head — SIGNATURE ORTHOPAEDICS PTY LTD · Class II

Cleared under the same submission

K955473 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 d4e33f54-bb83-4bb2-82c8-52afc0d509e7 36 fields · synced Jun 8, 2026