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Zimmer Biomet™ X Series Power System

FDA UDI

Class I (US FDA UDI)

by Zimmer Surgical SA

Identity

Trade Name
Zimmer Biomet™ X Series Power System FDA UDI
Generic Name
Bone/joint surgical power tool motor, electric FDA UDI
Model / Reference
89852040010 FDA UDI

Identifiers

Catalog Number
89-8520-400-10 FDA UDI
Primary DI / UDI-DI
00889024521124 FDA UDI
FDA Product Code
GEY FDA UDI
GMDN Term
Bone/joint surgical power tool motor, electric FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4820 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone/joint surgical power tool motor, electric

Zimmer Biomet™ X Series Power System by Zimmer Surgical SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone/joint surgical power tool motor, electric.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zimmer Surgical SA

Sources (1)

  • FDA UDI c2e6c6b9-1f54-40d7-96f4-931bf210970f 34 fields · synced May 30, 2026