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T2 Sceptor Spinal System

by Medtronic Sofamor Danek, Inc.

510(k) K063491

T2 Sceptor Spinal System is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K063491 on 5 Mar 2007, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063491 Date5 Mar 2007ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MQP
FDA applicant
Medtronic Sofamor Danek
Device class
Class II
Regulation
21 CFR Part 888.3060
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K063491

10 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K063491
UDI-DISize and differences
T2 SCEPTOR™ Spinal System 9351904
MEDTRONIC SOFAMOR DANEK, INC.
935190400613994218773 —No longer on the market
T2 SCEPTOR™ Spinal System 9351908
MEDTRONIC SOFAMOR DANEK, INC.
935190800613994218780 —No longer on the market
T2 SCEPTOR™ Spinal System 9351915
MEDTRONIC SOFAMOR DANEK, INC.
935191500613994218797 —No longer on the market
T2 SCEPTOR™ Spinal System 9352200
MEDTRONIC SOFAMOR DANEK, INC.
935220000613994218803 —On the market
T2 SCEPTOR™ Spinal System 9352204
MEDTRONIC SOFAMOR DANEK, INC.
935220400613994218810 —On the market
T2 SCEPTOR™ Spinal System 9352208
MEDTRONIC SOFAMOR DANEK, INC.
935220800613994218827 —No longer on the market
T2 SCEPTOR™ Spinal System 9352215
MEDTRONIC SOFAMOR DANEK, INC.
935221500613994218834 —No longer on the market
T2 SCEPTOR™ Spinal System 9352500
MEDTRONIC SOFAMOR DANEK, INC.
935250000613994218841 —On the market
T2 SCEPTOR™ Spinal System 9352504
MEDTRONIC SOFAMOR DANEK, INC.
935250400613994218858 —No longer on the market
T2 SCEPTOR™ Spinal System 9352515
MEDTRONIC SOFAMOR DANEK, INC.
935251500613994218872 —No longer on the market

Similar devices

Other devices filed under FDA product code MQP (Spinal Vertebral Body Replacement Device).

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