Accu-Joint

FDA UDI

Class II (US FDA UDI)

by Accufix Surgical, Inc.

Identity

Trade Name: Accu-Joint FDA UDI
Generic Name: Partial metatarsophalangeal joint prosthesis FDA UDI
Device Name: Accu-Joint Hemi Implant - Phalangeal 17mm - SUS FDA UDI
Model / Reference: AJPI-P17-SUS FDA UDI
Description: Accu-Joint Hemi Implant - Phalangeal 17mm - SUS FDA UDI

Identifiers

Catalog Number: AJPI-P17-SUS FDA UDI
Primary DI / UDI-DI: 00850061635341 FDA UDI
FDA Product Code: KWD FDA UDI
GMDN Term: Partial metatarsophalangeal joint prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3730 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

Yes

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Partial metatarsophalangeal joint prosthesis

Accu-Joint by Accufix Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Partial metatarsophalangeal joint prosthesis.

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MDI — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
TOE NON POROUS COATED SMALL 17mm — BIOPRO, INC. · Class II
OsteoMed — Osteomed Corp. · U
Arthrex® — Arthrex, Inc. · Class II
MDI — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
HemiCAP® — ARTHROSURFACE INCORPORATED · Class II
TOE JOINT NPC 8.75mm W/HOLE — BIOPRO, INC. · Class II

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: Accufix Surgical, Inc.

Sources (1)

FDA UDI 6781b2d6-6916-43b0-9615-acb42cdd6217 34 fields · synced May 30, 2026