Identity
- Trade Name
- Leucadia Pedicle Screw System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- POLYAXIAL SCREW, 8mm x 80mm FDA UDI
- Model / Reference
- LC-PS0880 FDA UDI
- Description
- POLYAXIAL SCREW, 8mm x 80mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844856076020 FDA UDI
- 510(k) Number
- K110588 FDA UDI
- FDA Product Code
- KWQ FDA UDIMNI FDA UDIKWP FDA UDIMNH FDA UDINKB FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 FDA UDI888.3070 FDA UDI888.3050 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
Dimensions & Sizes
- Size
- Outer Diameter — 8 Millimeter FDA UDILength — 80 Millimeter FDA UDI
Leucadia Pedicle Screw System by Alphatec Spine, 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
- Alphatec Spine, Inc.
Sources (1)
- FDA UDI ec20b400-078f-4512-9b1a-91b0e5c13fe2 36 fields · synced Jun 8, 2026