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BioPoly® Great Toe Hemiarthroplasty Implant
FDA UDIClass II (US FDA UDI)
by BioPoly, LLC
Identity
- Trade Name
- BioPoly® Great Toe Hemiarthroplasty Implant FDA UDI
- Generic Name
- Partial metatarsophalangeal joint prosthesis FDA UDI
- Device Name
- BioPoly® Great Toe Hemiarthroplasty Implant - 14mm Porous FDA UDI
- Model / Reference
- 135-5114 FDA UDI
- Description
- BioPoly® Great Toe Hemiarthroplasty Implant - 14mm Porous FDA UDI
Identifiers
- Catalog Number
- 135-5114 FDA UDI
- Primary DI / UDI-DI
- 00850012119388 FDA UDI
- 510(k) Number
- K203634 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
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 14 Millimeter FDA UDI
Category: Partial metatarsophalangeal joint prosthesis
BioPoly® Great Toe Hemiarthroplasty Implant by BioPoly, LLC — 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
- Accu-Joint — ACCUFIX SURGICAL, INC. · Class II
- TOE NON POROUS COATED SMALL 17mm — BIOPRO, 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
Cleared under the same submission
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
- BioPoly, LLC
Sources (1)
- FDA UDI 72afac1d-d93a-462e-aa3e-5000a76f8ff7 37 fields · synced May 30, 2026