VerSys®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: VerSys® FDA UDI
Generic Name: Press-fit femoral stem prosthesis FDA UDI
Model / Reference: 7843-11-16 FDA UDI

Identifiers

Catalog Number: 00-7843-011-16 FDA UDI
Primary DI / UDI-DI: 00889024136427 FDA UDI
510(k) Number: K042776 FDA UDI
K973714 FDA UDI
FDA Product Code: LZO FDA UDI
LPH FDA UDI
GMDN Term: Press-fit femoral stem prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3358 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: Press-fit femoral stem prosthesis

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

Similar devices

Also classified as Press-fit femoral stem prosthesis.

Echo® Bi-Metric® Hip System — Biomet Orthopedics, Inc. · Class II
Novation — Exactech, Inc. · Class II
Restoration — Howmedica Osteonics Corp. · Class II
DJO SURGICAL — ENCORE MEDICAL, L.P. · Class III
Restoration — Howmedica Osteonics Corp. · Class II
OrthoMedFlex — ORTHOMEDFLEX LLC · Class II
BI-METRIC X-SERIES HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Accolade — Howmedica Osteonics Corp. · Class II

Cleared under the same submission

K042776 also covers:

K973714 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Zimmer, Inc.

Sources (1)

FDA UDI 85a34d57-98d3-4ab1-a6f3-aa569be92dce 36 fields · synced Jun 8, 2026