Alliant Biotech

FDA UDI

Class II (US FDA UDI)

by Medisurge

Identity

Trade Name: Alliant Biotech FDA UDI
Generic Name: Joint prosthesis implantation kit, reusable FDA UDI
Device Name: Quatro-M Femoral Broach Case FDA UDI
Model / Reference: WH-2-1000 FDA UDI
Description: Quatro-M Femoral Broach Case FDA UDI

Identifiers

Catalog Number: WH-2-1000 FDA UDI
Primary DI / UDI-DI: G611WH210000 FDA UDI
510(k) Number: K033313 FDA UDI
FDA Product Code: LPH FDA UDI
LZO FDA UDI
LWJ FDA UDI
GMDN Term: Joint prosthesis implantation kit, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3358 FDA UDI
888.3353 FDA UDI
888.3360 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: Joint prosthesis implantation kit, reusable

Alliant Biotech by Medisurge — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Joint prosthesis implantation kit, reusable.

Initia Total Hip System — Kyocera Corporation · Class II
PROPHECY — MicroPort Orthopedics Inc. · Class II
Cadence Total Ankle System — Smith & Nephew, Inc. · Class I
IMPLANT PARTNERS™ — MicroPort Orthopedics Inc. · Class I
Evolution — MicroPort Orthopedics Inc. · Class II
GUARDIAN® — MicroPort Orthopedics Inc. · Class I
ADVANCE® — MicroPort Orthopedics Inc. · Class I
PROPHECY — MicroPort Orthopedics Inc. · Class II

Cleared under the same submission

K033313 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: Medisurge

Sources (1)

FDA UDI 99aae0bf-bfc0-4187-a15f-a15165863045 36 fields · synced May 30, 2026