Identity
- Trade Name
- Solar™ Interbody Fusion System FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- 34W X 24D X 14H X 0° Solar™ Trial FDA UDI
- Model / Reference
- 12-04T342414L00 FDA UDI
- Description
- 34W X 24D X 14H X 0° Solar™ Trial FDA UDI
Identifiers
- Catalog Number
- 12-04T342414L00 FDA UDI
- Primary DI / UDI-DI
- 00842048171751 FDA UDI
- 510(k) Number
- K231199 FDA UDI
- FDA Product Code
- OVD FDA UDIMAX FDA UDIPHM FDA UDI
- GMDN Term
- Spinal implant trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal implant trial
Solar™ Interbody Fusion System by Degen Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K231199 also covers:
- Solar™ Interbody Fusion System — Degen Medical
- Solar™ Interbody Fusion System — Degen Medical
- Solar™ Interbody Fusion System — Degen Medical
- Solar™ Interbody Fusion System — Degen Medical
- Solar™ Interbody Fusion System — Degen Medical
- Solar™ Interbody Fusion System — Degen Medical
- Solar™ Interbody Fusion System — Degen Medical
- Solar™ Interbody Fusion System — Degen Medical
- Solar™ Interbody Fusion System — Degen Medical
- Solar™ Interbody Fusion System — Degen Medical
- Solar™ Interbody Fusion System — Degen Medical
- Solar™ Interbody Fusion System — Degen Medical
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Degen Medical
Sources (1)
- FDA UDI 03519ab5-32f7-4c03-90fc-3bcc99102545 37 fields · synced May 31, 2026