Identity
- Trade Name
- TIGER Spine System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system FDA UDI
- Device Name
- 5500 SERIES CANNULATED SCREW MONO-AXIAL 8.5MM X 110MM FDA UDI
- Model / Reference
- 77685-110 FDA UDI
- Description
- 5500 SERIES CANNULATED SCREW MONO-AXIAL 8.5MM X 110MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- M725776851100 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH FDA UDIKWP FDA UDINKB FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 8.5 Millimeter FDA UDILength — 110 Millimeter FDA UDI
Category: Bone-screw internal spinal fixation system
TIGER Spine System by Corelink Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system.
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- APEX Spine System — SPINECRAFT LLC · Class II
- FIREBIRD — Orthofix US LLC · Class II
- FIREBIRD — Orthofix US LLC · Class II
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
- Corelink Llc
Sources (1)
- FDA UDI 8dfbf9b9-8f23-49f3-99f8-e643c718fe15 35 fields · synced Jun 8, 2026