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T2 SCEPTOR™ Spinal System 9351915

by Medtronic Sofamor Danek, Inc.

T2 SCEPTOR™ Spinal System 9351915 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K063491 on 5 Mar 2007 and listed in FDA GUDID since 21 Aug 2015 (UDI-DI 00613994218797), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K063491

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 Number00613994218797 UDI-DI Date21 Aug 2015ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK063491 Date5 Mar 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K063491 decided 5 Mar 2007 Active
  • FDA GUDID UDI-DI 00613994218797 listed 21 Aug 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K063491
  2. Listed FDA GUDID 00613994218797

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
T2 SCEPTOR™ Spinal System
Generic name
Polymeric spinal interbody fusion cage
Model / reference
9351915
Primary DI / UDI-DI
00613994218797
510(k) Number
FDA product code
MQP
GMDN term
Polymeric spinal interbody fusion cage
Device class
Class II
Regulation number
888.3060
GUDID distribution status
Not in Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K063491)

Similar devices

Other devices filed under FDA product code MQP (SPINAL VERTEBRAL BODY REPLACEMENT DEVICE).

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

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