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Explorer TO ET1-143008

by SeaSpine Orthopedics Corporation

Explorer TO ET1-143008 is a Class II device made by SeaSpine Orthopedics Corporation, cleared under FDA 510(k) K193418 on 13 Mar 2020 and listed in FDA GUDID since 1 Sep 2020 (UDI-DI 10889981184919), 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

510(k) K193418

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10889981184919 UDI-DI Date1 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK193418 Date13 Mar 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193418 decided 13 Mar 2020 Active
  • FDA GUDID UDI-DI 10889981184919 listed 1 Sep 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K193418
  2. Listed FDA GUDID 10889981184919

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Explorer TO
Generic name
Metal-polymer composite spinal interbody fusion cage
Model / Ref / Catalog
ET1-143008
Primary DI / UDI-DI
10889981184919
510(k) Number
FDA product code
MAX
GMDN term
Metal-polymer composite spinal interbody fusion cage
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Metal-polymer composite spinal interbody fusion cage

Cleared under the same submission (K193418)

and 8 more cleared under K193418

Similar devices

Other devices filed under FDA product code MAX (Intervertebral fusion device with bone graft, lumbar).

Other devices from SeaSpine Orthopedics Corporation

See all devices from SeaSpine Orthopedics Corporation →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)