Identity
- Trade Name
- Parallel Wire Guide FDA UDI
- Generic Name
- Orthopaedic guidewire, reusable FDA UDI
- Device Name
- Parallel Wire Guide FDA UDI
- Model / Reference
- 2004-0002 FDA UDI
- Description
- Parallel Wire Guide FDA UDI
Identifiers
- Catalog Number
- 2004-0002 FDA UDI
- Primary DI / UDI-DI
- 00816950027864 FDA UDI
- 510(k) Number
- K170021 FDA UDI
- FDA Product Code
- FZX FDA UDI
- GMDN Term
- Orthopaedic guidewire, reusable 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
Category: Orthopaedic guidewire, reusable
Parallel Wire Guide by OsteoCentric Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic guidewire, reusable.
- Orthopaedic Spreader — Synthes GmbH · Class IIa
- LCP — Synthes GmbH · Class IIa
- Guide Wire — I.T.S. GmbH · Class I
- Parallel Wire Guide, for φ2.5 Guide Wire, Adjustable — Double Medical Technology Inc. · Class II
- VERTECEM — Synthes GmbH · Class IIa
- Adapter Fibre Optic Cable Light Cable — Synthes GmbH · Class I
- ZERO-P — Synthes GmbH · Class IIa
- Guidewire, Nitinol, Double Blunt, 1.19 x 610mm — Captiva Spine · 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 5a3f56b4-6ac4-4220-b518-25689e829bb3 36 fields · synced Jun 8, 2026