Identity
- Trade Name
- E3D®-C Interbody System FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Device Name
- E3D-C INTERBODY ANCHOR INSERTER 10mm FDA UDI
- Model / Reference
- 132-A007 FDA UDI
- Description
- E3D-C INTERBODY ANCHOR INSERTER 10mm FDA UDI
Identifiers
- Catalog Number
- 132-A007 FDA UDI
- Primary DI / UDI-DI
- 00195860026977 FDA UDI
- 510(k) Number
- K241846 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical drill guide, 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: Surgical drill guide, 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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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 e58df7c3-7485-4964-9162-df0ee38d2e1f 36 fields · synced May 30, 2026