Identity
- Trade Name
- Futura™ CSI FDA UDI
- Generic Name
- Partial metatarsophalangeal joint prosthesis FDA UDI
- Device Name
- Conical Subtalar Implant FDA UDI
- Model / Reference
- CSI-12 FDA UDI
- Description
- Conical Subtalar Implant FDA UDI
Identifiers
- Catalog Number
- CSI-12 FDA UDI
- Primary DI / UDI-DI
- 00846832006335 FDA UDI
- 510(k) Number
- K032902 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Partial metatarsophalangeal joint prosthesis 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 12 Millimeter FDA UDI
Category: Partial metatarsophalangeal joint prosthesis
Futura™ CSI by Tornier, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K032902 also covers:
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
- Tornier, Inc.
Sources (1)
- FDA UDI 010dfbf3-4523-4558-a6d4-b14d729d89f1 37 fields · synced Jun 8, 2026