Identity
- Trade Name
- Kyocera Medical Technologies, Inc. FDA UDI
- Generic Name
- Orthopaedic bone screw (non-sliding) FDA UDI
- Device Name
- 7.5mm Cannulated Screw, 20 Thread, L 100mm 316L SS FDA UDI
- Model / Reference
- T 700 FDA UDI
- Description
- 7.5mm Cannulated Screw, 20 Thread, L 100mm 316L SS FDA UDI
Identifiers
- Catalog Number
- 1703-753-100 FDA UDI
- Primary DI / UDI-DI
- 00841523117048 FDA UDI
- 510(k) Number
- K113084 FDA UDI
- FDA Product Code
- HWC FDA UDIHTN FDA UDI
- GMDN Term
- Orthopaedic bone screw (non-sliding) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Kyocera Medical Technologies, Inc. by Kyocera Medical Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Kyocera Medical Technologies, Inc.
Sources (1)
- FDA UDI 5dfc04f5-7a9d-4301-989f-3666a0264c39 36 fields · synced May 31, 2026