T2 SCEPTOR™ Spinal System 9352504
by Medtronic Sofamor Danek, Inc.
T2 SCEPTOR™ Spinal System 9352504 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 18 Aug 2015 (UDI-DI 00613994218858), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00613994218858 | Date18 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK063491 | Date5 Mar 2007 | StatusActive |
Official records
- AccessGUDID record 00613994218858
- FDA 510(k) database K063491
Across registries
- FDA 510(k) K063491 decided 5 Mar 2007 Active
- FDA GUDID UDI-DI 00613994218858 listed 18 Aug 2015 Listed
Timeline
- Cleared FDA 510(k) K063491
- Listed FDA GUDID 00613994218858
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- T2 SCEPTOR™ Spinal System
- Generic name
- Polymeric spinal interbody fusion cage
- Model / reference
- 9352504
- Primary DI / UDI-DI
- 00613994218858
- 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
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