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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 - Metatarsal 18mm-2 - SUS FDA UDI
Model / Reference
AJMI-M18-2-SUS FDA UDI
Description
Accu-Joint Hemi Implant - Metatarsal 18mm-2 - SUS FDA UDI

Identifiers

Catalog Number
AJMI-M18-2-SUS FDA UDI
Primary DI / UDI-DI
00850061635266 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Partial metatarsophalangeal joint prosthesis

The Accu-Joint is a medical device designed to repair an articulating surface of the metatarsophalangeal (MTP) joint in the foot, treating degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.

Similar devices

Also classified as Partial metatarsophalangeal joint prosthesis.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Accufix Surgical, Inc.

Sources (1)

  • FDA UDI 2efd8aa7-ed9b-4232-b24d-b7f80f95ea6d 34 fields · synced Jun 19, 2026