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OsteoCentric 2.70mm Guidewire, Threaded Trocar Tip, 450mm CoCr
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- OsteoCentric 2.70mm Guidewire, Threaded Trocar Tip, 450mm CoCr FDA UDI
- Generic Name
- Orthopaedic guidewire, single-use FDA UDI
- Device Name
- 2.70mm Guidewire, Threaded Trocar Tip, 450mm Cobalt Chrome FDA UDI
- Model / Reference
- 2004-0025 FDA UDI
- Description
- 2.70mm Guidewire, Threaded Trocar Tip, 450mm Cobalt Chrome FDA UDI
Identifiers
- Catalog Number
- 2004-0025 FDA UDI
- Primary DI / UDI-DI
- 00816950024894 FDA UDI
- 510(k) Number
- K200259 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Orthopaedic guidewire, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Guidewire Length — 450 Millimeter FDA UDIGuidewire Diameter — 2.70 Millimeter FDA UDI
Category: Orthopaedic guidewire, single-use
OsteoCentric 2.70mm Guidewire, Threaded Trocar Tip, 450mm CoCr by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID
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
- 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
- Flower Orthopedics — FLOWER ORTHOPEDICS CORPORATION · Class I
Cleared under the same submission
K200259 also covers:
- 2.8 mm Headless Compression Screw Fastener — OsteoCentric Technologies,Inc
- 2.8 mm Headless Compression Screw Fastener — OsteoCentric Technologies,Inc
- 2.8 mm Headless Compression Screw Fastener — OsteoCentric Technologies,Inc
- 2.8 mm Headless Compression Screw Fastener — OsteoCentric Technologies,Inc
- 2.8 mm Headless Compression Screw Fastener — OsteoCentric Technologies,Inc
- 2.8 mm Headless Compression Screw Fastener — OsteoCentric Technologies,Inc
- 2.8 mm Headless Compression Screw Fastener — OsteoCentric Technologies,Inc
- 2.8 mm Headless Compression Screw Fastener — OsteoCentric Technologies,Inc
- 2.8 mm Headless Compression Screw Fastener — OsteoCentric Technologies,Inc
- 2.8mm x 12mm HCS — OsteoCentric Technologies,Inc
- 2.8mm x 14mm HCS — OsteoCentric Technologies,Inc
- 2.8mm x 18mm HCS — OsteoCentric Technologies,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 I | Pending data |
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Manufacturer
- Manufacturer
- OsteoCentric Technologies, Inc
Sources (1)
- FDA UDI 6c9472ed-5985-4bf9-848c-4a9556b3663f 37 fields · synced May 30, 2026