Identity
- Trade Name
- OptimalMTP™ FDA UDI
- Generic Name
- Orthopaedic guidewire, single-use FDA UDI
- Device Name
- 1.4mm Olive K-wire, 4 in. Long FDA UDI
- Model / Reference
- 6102.2114 FDA UDI
- Description
- 1.4mm Olive K-wire, 4 in. Long FDA UDI
Identifiers
- Catalog Number
- 6102.2114 FDA UDI
- Primary DI / UDI-DI
- 00810136432947 FDA UDI
- 510(k) Number
- K230945 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic guidewire, 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 UDILength — 4 Inch FDA UDI
Category: Orthopaedic guidewire, single-use
OptimalMTP™ by Forma Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic guidewire, single-use.
- OrthoPediatrics PediFoot Deformity Correction System — ORTHOPEDIATRICS CORP. · Class II
- Gen II Cannulated Screws — ORTHOPEDIATRICS CORP. · Class II
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- 2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc · Class I
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- Stainless Steel Guide Wires — ORTHOPEDIATRICS CORP. · Class I
- Ball Tip Wire — Orthopedic Designs North America, Inc. · Class I
- HINGE PEDIATRIC PLATING SYSTEM — Orthopediatrics Canada ULC · Class I
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 183b7e75-015f-49a4-a290-0f929b14c2c5 37 fields · synced Jun 6, 2026