Identity
- Trade Name
- Subtalar MBA Implant System FDA UDI
- Generic Name
- Subtalar implant, non-bioabsorbable FDA UDI
- Device Name
- SUBTALAR MBA IMPLANT. 12MM FDA UDI
- Model / Reference
- 050112 FDA UDI
- Description
- SUBTALAR MBA IMPLANT. 12MM FDA UDI
Identifiers
- Catalog Number
- 050112 FDA UDI
- Primary DI / UDI-DI
- 00885556865910 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Subtalar implant, non-bioabsorbable
Subtalar MBA Implant System by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Subtalar implant, non-bioabsorbable.
- HORIZON HYBRID SUBTALAR 12MM — BIOPRO, INC. · Class II
- HORIZON SUBTALAR GEN 2 10MM — BIOPRO, INC. · Class II
- LSI Arthroereisis Peg — FUSION ORTHOPEDICS, LLC · Class II
- HyProCure II Sinus Tarsi Stent Size 06 — Gramedica · Class II
- HORIZON TITANIUM SUBTALAR 12MM — BIOPRO, INC. · Class II
- HORIZON TITANIUM SUBTALAR 6MM — BIOPRO, INC. · Class II
- bioBLOCK® Subtalar Implant System — Ascension Orthopedics, Inc. · Class II
- HORIZON SUBTALAR GEN 2 6MM — BIOPRO, INC. · Class II
Cleared under the same submission
K210016 also covers:
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
- Capture Screw System — Smith & Nephew, Inc.
K960692 also covers:
- MBA™ Titanium Subtalar Implant System — Ascension Orthopedics, Inc.
- MBA™ Titanium Subtalar Implant System — Ascension Orthopedics, Inc.
- MBA™ Titanium Subtalar Implant System — Ascension Orthopedics, Inc.
- MBA™ Titanium Subtalar Implant System — Ascension Orthopedics, Inc.
- MBA™ Titanium Subtalar Implant System — Ascension Orthopedics, Inc.
- Subtalar MBA Implant System — Smith & Nephew, Inc.
- Subtalar MBA Implant System — Smith & Nephew, Inc.
- Subtalar MBA Implant System — Smith & Nephew, Inc.
- Subtalar MBA Implant System — Smith & Nephew, 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 54433a1b-4f7d-440f-9dae-d61415c763a9 36 fields · synced Jun 8, 2026