Identity
- Trade Name
- Lineum® OCT FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, sterile FDA UDI
- Model / Reference
- 14-524941E FDA UDI
Identifiers
- Catalog Number
- 14-524941E FDA UDI
- Primary DI / UDI-DI
- 00880304982758 FDA UDI
- FDA Product Code
- MNH FDA UDIKWP FDA UDIMNI FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, sterile 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bone-screw internal spinal fixation system, sterile
Lineum® OCT by Biomet Spine Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system, sterile.
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- Mont Blanc MIS Spinal Systems — Spineway SA · Class II
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- VERTICALE — Silony Medical GmbH · Class II
- Mont Blanc MIS Spinal Systems — Spineway SA · 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
- Biomet Spine Llc
Sources (1)
- FDA UDI cc6735b0-d21f-4bd5-9723-ab1c810d4569 35 fields · synced Jun 1, 2026