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E3D-C Interbody System 130G-2XL0712

by Evolution Spine, LLC

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10195860030698 UDI-DI Date20 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK260038 Date4 Feb 2026DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Metallic spinal interbody fusion cage
Model / Ref / Catalog
130G-2XL0712
Primary DI / UDI-DI
10195860030698
510(k) Number
FDA product code
OVE, ODP
GMDN term
Metallic spinal interbody fusion cage
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K241846)

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Cleared under the same submission (K260038)

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Lot / batch number

Other properties (11)

  • Sterilise before use: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No