Identity
- Trade Name
- 4.5mm BONE-LOK PLS Implant FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, sterile FDA UDI
- Device Name
- 4.5mm O.D. x 30-40mm Length FDA UDI
- Model / Reference
- LSW-45-3040 FDA UDI
- Description
- 4.5mm O.D. x 30-40mm Length FDA UDI
Identifiers
- Catalog Number
- 9024-00 FDA UDI
- Primary DI / UDI-DI
- 81195401002786 FDA UDI
- FDA Product Code
- MRW FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, sterile FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
4.5mm BONE-LOK PLS Implant by Interventional Spine, Inc — Class U — 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 U | Pending data |
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Manufacturer
- Manufacturer
- Interventional Spine, Inc
Sources (1)
- FDA UDI 7b7b98fe-a75f-4735-a1ae-0fc66b8e1ad9 36 fields · synced Jun 6, 2026