Identity
- Trade Name
- E3D®-C Interbody System FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- SHORT FIXED ANGLE OUTER HOUSING FDA UDI
- Model / Reference
- 130-A120 FDA UDI
- Description
- SHORT FIXED ANGLE OUTER HOUSING FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00195860029930 FDA UDI
- 510(k) Number
- K241846 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical screwdriver, 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
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
Category: Surgical screwdriver, reusable
E3D®-C Interbody System by Evolution Spine, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical screwdriver, reusable.
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- LOSPA IS Spinal Fixation System — Corentec Co., Ltd · Class II
- PERLA ® TL — Spineart · Class II
- USS — Synthes · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
- KLOCKNER — SOADCO, S.L. · Class I
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 0e8396b1-845d-4f00-ac79-984783c807a1 35 fields · synced Jun 8, 2026