Identity
- Trade Name
- Stylet, 285mm FDA UDI
- Generic Name
- Orthopaedic guidewire, single-use FDA UDI
- Device Name
- Stylet, 285mm FDA UDI
- Model / Reference
- 2004-0011 FDA UDI
- Description
- Stylet, 285mm FDA UDI
Identifiers
- Catalog Number
- 2004-0011 FDA UDI
- Primary DI / UDI-DI
- 00816950027949 FDA UDI
- 510(k) Number
- K170021 FDA UDI
- FDA Product Code
- GAH FDA UDI
- GMDN Term
- Orthopaedic guidewire, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
- Length — 285 Millimeter FDA UDI
Category: Orthopaedic guidewire, single-use
Stylet, 285mm by OsteoCentric Technologies, Inc — Class I — 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
- 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
K170021 also covers:
- 1.6mm Guide Wire Smooth Trocar 150mm — OsteoCentric Technologies,Inc
- 2.5mm Hex Driver Cann Fixed — OsteoCentric Technologies,Inc
- 2.5mm Hex Driver, AO QC Shaft 290mm — OsteoCentric Technologies,Inc
- 2.5mm Hex Driver, Fixed 290mm — OsteoCentric Technologies,Inc
- 2.74mm Guidewire, Threaded Trocar Tip SS, 450mm — OsteoCentric Technologies,Inc
- 2.7mm Guidewire, Drill Tip, 300mm — OsteoCentric Technologies,Inc
- 2.8 x 125mm Drill Bit Cann AO — OsteoCentric Technologies,Inc
- 2.8/3.5mm Double Drill Guide — OsteoCentric Technologies,Inc
- 4.0 X 105mm CANN SCREW FASTENER Ti SH THD — OsteoCentric Technologies,Inc
- 4.0 X 110mm CANN SCREW FASTENER Ti SH THD — OsteoCentric Technologies,Inc
- 4.0 X 115mm CANN SCREW FASTENER Ti FL THD — OsteoCentric Technologies,Inc
- 4.0 X 115mm CANN SCREW FASTENER Ti LG THD — 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 0f35abba-d8c3-4b4d-ac3f-6fb161f868e6 37 fields · synced Jun 8, 2026