Identity
- Trade Name
- REDUCT® Headless Compression Screw FDA UDI
- Generic Name
- Orthopaedic intraoperative positioning pin, single-use FDA UDI
- Model / Reference
- K-Wire, HCS, 1.4mm x 165mm FDA UDI
Identifiers
- Catalog Number
- KWIR-HCS-14165 FDA UDI
- Primary DI / UDI-DI
- 00841506102481 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Orthopaedic intraoperative positioning pin, 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
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 1.4 Millimeter FDA UDI
Category: Orthopaedic intraoperative positioning pin, single-use
REDUCT® Headless Compression Screw by Skeletal Dynamics L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic intraoperative positioning pin, single-use.
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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
- Skeletal Dynamics L.l.c.
Sources (1)
- FDA UDI 716ba0f5-562f-4c48-915c-467612d13788 35 fields · synced May 31, 2026