Identity
- Trade Name
- TOE POROUS COATED MEDIUM 20mm FDA UDI
- Generic Name
- Partial metatarsophalangeal joint prosthesis FDA UDI
- Model / Reference
- 10413 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209104130 FDA UDI
- 510(k) Number
- K041595 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Partial metatarsophalangeal joint prosthesis
TOE POROUS COATED MEDIUM 20mm by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Partial metatarsophalangeal joint prosthesis.
- MDI — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Accu-Joint — ACCUFIX SURGICAL, INC. · Class II
- Accu-Joint — ACCUFIX SURGICAL, INC. · Class II
- OsteoMed — Osteomed Corp. · U
- Arthrex® — Arthrex, Inc. · Class II
- MDI — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- HemiCAP® — ARTHROSURFACE INCORPORATED · Class II
- SWANSON — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Cleared under the same submission
K041595 also covers:
- 5-Star Template — BIOPRO, INC.
- CHISEL — BIOPRO, INC.
- FIRST MPJ HEMI COMPLETE KIT — BIOPRO, INC.
- First MPJ Instrument Tray — BIOPRO, INC.
- Impactor Tip LG — BIOPRO, INC.
- LESSER MPJ TRIAL 10.25MM — BIOPRO, INC.
- LESSER MPJ TRIAL 11.0MM — BIOPRO, INC.
- LESSER MPJ TRIAL 14.00MM — BIOPRO, INC.
- MPJ TRIAL 17mm (SM) — BIOPRO, INC.
- MPJ TRIAL 20mm (MD) — BIOPRO, INC.
- MPJ TRIAL 21.5mm (ML) — BIOPRO, INC.
- MPJ Trial 21.5mm (ML) — BIOPRO, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI 76fb1823-826c-42be-8ba2-6a4e38395102 33 fields · synced May 30, 2026