Ultra-Drive®

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: ULTRA-DRIVE® FDA UDI
Generic Name: Surgical power tool irrigation-control device FDA UDI
Model / Reference: 423833 FDA UDI

Identifiers

Catalog Number: 423833 FDA UDI
Primary DI / UDI-DI: 00880304372917 FDA UDI
510(k) Number: K031280 FDA UDI
K900003 FDA UDI
FDA Product Code: JDX FDA UDI
GMDN Term: Surgical power tool irrigation-control device FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.4580 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Surgical power tool irrigation-control device

Ultra-Drive® by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical power tool irrigation-control device.

ULTRA DRIVE IRRIGATION — Biomet Orthopedics, Inc. · Class II
ULTRA-DRIVE® — Biomet Orthopedics, Inc. · Class II
ULTRA-DRIVE III IRRIGATION CLIP — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

K900003 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: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI e0e128b2-ba0f-4919-bdec-c14c045857eb 35 fields · synced May 30, 2026