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E3D-C Interbody System 130-A178

by Evolution Spine, LLC

E3D-C Interbody System 130-A178 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 00195860032299), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00195860032299 UDI-DI Date20 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK260038 Date4 Feb 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K260038 decided 4 Feb 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00195860032299 listed 20 Feb 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K241846
  2. Cleared FDA 510(k) K260038
  3. Listed FDA GUDID 00195860032299

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
E3D-C Interbody System
Generic name
Spinal implant trial
Model / Ref / Catalog
130-A178
Primary DI / UDI-DI
00195860032299
510(k) Number
FDA product code
LXH
GMDN term
Spinal implant trial
Device class
Class I
Regulation number
888.4540
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K241846)

and 8 more cleared under K241846

Cleared under the same submission (K260038)

and 8 more cleared under K260038

Similar devices

Other devices filed under FDA product code LXH (Orthopedic manual surgical instrument).

Other devices from Evolution Spine, LLC

See all devices from Evolution Spine, LLC →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)