Identity
- Trade Name
- TiLock FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- 8.5mm x 80mm Modular Solid Dual Thread Screw FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 8.5mm x 80mm Modular Solid Dual Thread Screw FDA UDI
Identifiers
- Catalog Number
- GMSD85-80 FDA UDI
- Primary DI / UDI-DI
- M719GMSD85800 FDA UDI
- FDA Product Code
- KWQ FDA UDIKWP FDA UDIMNI FDA UDIMNH FDA UDIOSH FDA UDINKB FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, 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
- 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
- Outer Diameter — 8.5 Millimeter FDA UDILength — 80 Millimeter FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
TiLock by Genesys Orthopedics Systems LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Genesys Orthopedics Systems LLC
Sources (1)
- FDA UDI 87451e0e-2336-4462-847f-49431663e4ad 36 fields · synced May 31, 2026