Identity
- Trade Name
- OptimalTMT™ FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- MIS Lapidus Clamp Medial Pad FDA UDI
- Model / Reference
- 6102.8009 FDA UDI
- Description
- MIS Lapidus Clamp Medial Pad FDA UDI
Identifiers
- Catalog Number
- 6102.8009 FDA UDI
- Primary DI / UDI-DI
- 00810136433449 FDA UDI
- 510(k) Number
- K230945 FDA UDI
- FDA Product Code
- HWC FDA UDIHRS FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 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
No
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
No
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
OptimalTMT™ by Forma Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230945 also covers:
- Handle — Forma Medical, Inc.
- OptimalHT™ — Forma Medical, Inc.
- OptimalHT™ — Forma Medical, Inc.
- OptimalHT™ — Forma Medical, Inc.
- OptimalHT™ — Forma Medical, Inc.
- OptimalHT™ — Forma Medical, Inc.
- OptimalHT™ — Forma Medical, Inc.
- OptimalHT™ — Forma Medical, Inc.
- OptimalHT™ — Forma Medical, Inc.
- OptimalHT™ — Forma Medical, Inc.
- OptimalHT™ — Forma Medical, Inc.
- OptimalHT™ — Forma Medical, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Forma Medical, Inc.
Sources (1)
- FDA UDI 8928414e-56dc-4506-9bbb-6b3ce7ae3615 35 fields · synced May 30, 2026