Identity
- Trade Name
- E3D®-C Interbody System FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- FIXED A/O HANDLE FDA UDI
- Model / Reference
- 130-A116 FDA UDI
- Description
- FIXED A/O HANDLE FDA UDI
Identifiers
- Catalog Number
- 130-A116 FDA UDI
- Primary DI / UDI-DI
- 00195860029893 FDA UDI
- 510(k) Number
- K241846 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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: Orthopaedic surgical procedure kit, non-medicated, reusable
E3D®-C Interbody System by Evolution Spine, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.
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Cleared under the same submission
K241846 also covers:
- E3D®-C Interbody System — EVOLUTION SPINE, LLC
- E3D®-C Interbody System — EVOLUTION SPINE, LLC
- E3D®-C Interbody System — EVOLUTION SPINE, LLC
- E3D®-C Interbody System — EVOLUTION SPINE, LLC
- E3D®-C Interbody System — EVOLUTION SPINE, LLC
- E3D®-C Interbody System — EVOLUTION SPINE, LLC
- E3D®-C Interbody System — EVOLUTION SPINE, LLC
- E3D®-C Interbody System — EVOLUTION SPINE, LLC
- E3D®-C Interbody System — EVOLUTION SPINE, LLC
- E3D®-C Interbody System — EVOLUTION SPINE, LLC
- E3D®-C Interbody System — EVOLUTION SPINE, LLC
- E3D®-C Interbody System — EVOLUTION SPINE, LLC
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 I | Pending data |
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Manufacturer
- Manufacturer
- Evolution Spine, Llc
Sources (1)
- FDA UDI 26f58e8a-08ff-4203-b3f0-037877f67fbb 36 fields · synced May 31, 2026