Identity
- Trade Name
- OptimalHT™ FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- MIS Targeting Instrument, Handled, 1.4mm Wire, With Elevator FDA UDI
- Model / Reference
- 6100.1009 FDA UDI
- Description
- MIS Targeting Instrument, Handled, 1.4mm Wire, With Elevator FDA UDI
Identifiers
- Catalog Number
- 6100.1009 FDA UDI
- Primary DI / UDI-DI
- 00810136430394 FDA UDI
- 510(k) Number
- K230945 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use 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
No
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
Dimensions & Sizes
- Size
- Outer Diameter — 1.4 Millimeter FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, single-use
OptimalHT™ by Forma Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.
- MyKnee PPS — Medacta International · Class II
- MyKnee — Medacta International · Class II
- MyKnee PPS — Medacta International · Class II
- MyKnee — Medacta International · Class II
- MyKnee — Medacta International · Class II
- My Knee Tibial Cutting Blocks MIS — Medacta International · Class II
- My Spine Low Profile Placement Guides — Medacta International · Class II
- MySpine Unilateral Guide — Medacta International · Class II
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 baa8c265-f0df-4558-beb1-3d63035ae117 37 fields · synced Jun 1, 2026