Identity
- Trade Name
- USS FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- 8.0MM TI USS VARIABLE AXIS SCREW 75MM THREAD LENGTH FDA UDI
- Model / Reference
- 499.662 FDA UDI
- Description
- 8.0MM TI USS VARIABLE AXIS SCREW 75MM THREAD LENGTH FDA UDI
Identifiers
- Catalog Number
- 499662 FDA UDI
- Primary DI / UDI-DI
- 10705034794570 FDA UDI
- FDA Product Code
- KWQ FDA UDIKWP FDA UDIMNI FDA UDIMNH FDA UDINKB FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3050 FDA UDI888.3070 FDA UDI
- Commercial Distribution
- Not 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
Uss by Synthes (u.s.a.) Lp — 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
- Synthes (u.s.a.) Lp
Sources (1)
- FDA UDI bd1f6e31-6ed3-434d-8cae-d3a894fbd593 36 fields · synced Jun 1, 2026