Identity
- Trade Name
- Accu-Joint FDA UDI
- Generic Name
- Partial metatarsophalangeal joint prosthesis FDA UDI
- Device Name
- Accu-Joint Hemi Implant - Metatarsal 10mm-2 FDA UDI
- Model / Reference
- AJMI-10-20-2 FDA UDI
- Description
- Accu-Joint Hemi Implant - Metatarsal 10mm-2 FDA UDI
Identifiers
- Catalog Number
- AJMI-10-20-2 FDA UDI
- Primary DI / UDI-DI
- 00850044114962 FDA UDI
- 510(k) Number
- K200951 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization 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.
- TOE JOINT TITANIUM NPC LG 23MM — BIOPRO, INC. · Class II
- 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
Cleared under the same submission
K200951 also covers:
- Accu-Joint — ACCUFIX SURGICAL, INC.
- Accu-Joint — ACCUFIX SURGICAL, INC.
- Accu-Joint — ACCUFIX SURGICAL, INC.
- Accu-Joint — ACCUFIX SURGICAL, INC.
- Accu-Joint — ACCUFIX SURGICAL, INC.
- Accu-Joint — ACCUFIX SURGICAL, INC.
- Accu-Joint — ACCUFIX SURGICAL, INC.
- Accu-Joint — ACCUFIX SURGICAL, INC.
- Accu-Joint — ACCUFIX SURGICAL, INC.
- Accu-Joint — ACCUFIX SURGICAL, INC.
- Accu-Joint — ACCUFIX SURGICAL, INC.
- Accu-Joint — ACCUFIX SURGICAL, INC.
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 291cde28-f593-4a7d-82ab-0d9c7c3afbc5 35 fields · synced Jun 1, 2026