Identity
- Trade Name
- HORIZON SUBTALAR GEN 2 10MM FDA UDI
- Generic Name
- Subtalar implant, non-bioabsorbable FDA UDI
- Model / Reference
- 22646 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M20922646 FDA UDI
- 510(k) Number
- K041936 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Subtalar implant, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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: Subtalar implant, non-bioabsorbable
Horizon Subtalar Gen 2 10mm by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Subtalar implant, non-bioabsorbable.
- Subtalar MBA Implant System — Smith & Nephew, Inc. · Class II
- LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC · Class II
- HyProCure II Sinus Tarsi Stent Size 06 — Gramedica · Class II
- bioBLOCK® Subtalar Implant System — Ascension Orthopedics, Inc. · Class II
- CORVUS — HNM TOTAL RECON LLC · Class II
- SUBTALAR SPACER SYSTEM — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- STA-PEG — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
- SUBTALAR SPACER SYSTEM — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
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 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.
- HORIZON TITANIUM SUBTALAR 10MM — 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 |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI d4ec0e38-882d-4b87-96c8-176c4e9d131d 33 fields · synced May 30, 2026