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DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- PLATE 2150018 OLIF51 PLATE 18MM FDA UDI
- Model / Reference
- 2150018 FDA UDI
- Description
- PLATE 2150018 OLIF51 PLATE 18MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169502505 FDA UDI
- 510(k) Number
- K150135 FDA UDI
- FDA Product Code
- MAX FDA UDIKWQ FDA UDIOVD FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI888.3060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Category: Orthopaedic fixation plate, non-bioabsorbable
DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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- Traufix osteosynthesis, osteotomy, and arthrodesis devices — Fixier S.A. DE C.V. · Class II
- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- AXSOS — Stryker Corp. · Class II
- Xpert Wrist — NEWCLIP TECHNICS · Class II
- ACUMED — ACUMED LLC · Class II
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- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Cleared under the same submission
K150135 also covers:
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System — MEDTRONIC SOFAMOR DANEK, INC.
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System — MEDTRONIC SOFAMOR DANEK, INC.
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System — MEDTRONIC SOFAMOR DANEK, INC.
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System — MEDTRONIC SOFAMOR DANEK, INC.
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System — MEDTRONIC SOFAMOR DANEK, INC.
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System — MEDTRONIC SOFAMOR DANEK, INC.
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System — MEDTRONIC SOFAMOR DANEK, INC.
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System — MEDTRONIC SOFAMOR DANEK, INC.
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System — MEDTRONIC SOFAMOR DANEK, INC.
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System — MEDTRONIC SOFAMOR DANEK, INC.
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System — MEDTRONIC SOFAMOR DANEK, INC.
- DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System — MEDTRONIC SOFAMOR DANEK, INC.
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
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI 90ec80b1-9be3-471e-b530-fa1f2cacc07f 36 fields · synced May 30, 2026