E3D-C Interbody System 130-A177
E3D-C Interbody System 130-A177 is a Class I device made by Evolution Spine, LLC, cleared under FDA 510(k) K260038 on 4 Feb 2026 (1 earlier submission) and listed in FDA GUDID since 20 Feb 2026 (UDI-DI 00195860032282), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00195860032282 | Date20 Feb 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK260038 | Date4 Feb 2026 | StatusActive |
Official records
- AccessGUDID record 00195860032282
- FDA 510(k) database K260038
- FDA 510(k) database K241846
Across registries
- FDA 510(k) K260038 decided 4 Feb 2026 Active
- FDA GUDID UDI-DI 00195860032282 listed 20 Feb 2026 Listed
Timeline
- Cleared FDA 510(k) K241846
- Cleared FDA 510(k) K260038
- Listed FDA GUDID 00195860032282
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- E3D-C Interbody System
- Generic name
- Spinal implant trial
- Model / Ref / Catalog
- 130-A177
- Primary DI / UDI-DI
- 00195860032282
- FDA product code
- LXH
- GMDN term
- Spinal implant trial
- Device class
- Class I
- Regulation number
- 888.4540
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code LXH (Orthopedic manual surgical instrument).
- INSTRUMENT 6496-3-101 by Howmedica Osteonics Corp.
- Knee Instruments 02.18.10.1079 by Medacta International SA
- ACUMED 80-4164 by ACUMED LLC
- Sayan 1042.37.003 by SAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETI
- APEX Knee System KS-40512 by OMNIlife science, Inc.
- PRO 703967 by Stryker GmbH
- NAPA Access System 8030-90204 by VB Spine LLC
- Spine Instruments 03.22.10.1055 by Medacta International SA
- Screwdriver Shaft 4812-045-03 00-4812-045-03 by Zimmer, Inc.
- Tornier Perform MWJ118 by TORNIER, INC.