Identity
- Trade Name
- Subtalar Pin Guide Gen II FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Model / Reference
- 23014 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M20923014 FDA UDI
- 510(k) Number
- K041936 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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: Orthopaedic prosthesis implantation positioning instrument, reusable
Subtalar Pin Guide Gen II by Biopro, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K041936 also covers:
- Driver — BIOPRO, INC.
- HORIZON HYBRID SUBTALAR 10MM — BIOPRO, INC.
- HORIZON HYBRID SUBTALAR 11MM — BIOPRO, INC.
- HORIZON HYBRID SUBTALAR 12MM — BIOPRO, INC.
- HORIZON HYBRID SUBTALAR 8MM — BIOPRO, INC.
- HORIZON HYBRID SUBTALAR 9MM — BIOPRO, INC.
- HORIZON SUBTALAR GEN 2 10MM — BIOPRO, INC.
- HORIZON SUBTALAR GEN 2 11MM — BIOPRO, INC.
- HORIZON SUBTALAR GEN 2 6MM — BIOPRO, INC.
- HORIZON SUBTALAR GEN 2 8MM — BIOPRO, INC.
- HORIZON SUBTALAR GEN 2 9MM — BIOPRO, INC.
- HORIZON SUBTALAR GEN 212MM — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI 42673f27-f43e-44e0-a952-2b4ed7f520e3 33 fields · synced May 30, 2026