Identity
- Trade Name
- OptimalTMT™ FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Titanium Long MIS Lapidus S-Plate, Right, 4 hole FDA UDI
- Model / Reference
- 1102.2304.17 FDA UDI
- Description
- Titanium Long MIS Lapidus S-Plate, Right, 4 hole FDA UDI
Identifiers
- Catalog Number
- 1102.2304.17 FDA UDI
- Primary DI / UDI-DI
- 00810136433463 FDA UDI
- 510(k) Number
- K230945 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate, 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
OptimalTMT™ by Forma Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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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 |
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Manufacturer
- Manufacturer
- Forma Medical, Inc.
Sources (1)
- FDA UDI 6bb97e34-0ac7-454e-bcae-841abf4c57aa 36 fields · synced Jun 8, 2026