X1203056
by Medtronic Sofamor Danek, Inc.
X1203056 is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K011443 on 3 Aug 2001 and listed in FDA GUDID since 5 Aug 2015 (UDI-DI 00885074000770), active 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 | Number00885074000770 | Date5 Aug 2015 | StatusListed |
| United States | FDA 510(k)SESU | NumberK011443 | Date3 Aug 2001 | StatusActive |
Official records
- AccessGUDID record 00885074000770
- FDA 510(k) database K011443
Across registries
- FDA 510(k) K011443 decided 3 Aug 2001 Active
- FDA GUDID UDI-DI 00885074000770 listed 5 Aug 2015 Listed
Timeline
- Cleared FDA 510(k) K011443
- Listed FDA GUDID 00885074000770
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Metal-polymer composite spinal interbody fusion cage
- Model / reference
- X1203056
- Primary DI / UDI-DI
- 00885074000770
- 510(k) Number
- FDA product code
- JDK
- GMDN term
- Metal-polymer composite spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 878.3300
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices
Other devices filed under FDA product code JDK (Prosthesis, hip, cement restrictor).
- FIDJI SMALL CEMENT RESTRICTOR by Spine Next SA
- SKELITE RESORBABLE CEMENT RESTRICTOR by Millenium Biologix, Inc.
- TRAXIS CEMENT RESTRICTOR by Spinal Concepts, Inc.
- MODIFICATION TO FORTITUDE CEMENT RESTRICTOR by Spinal Concepts, Inc.
- THEKEN LARGE CEMENT RESTRICTOR by Theken Surgical, Llc
- BONE CEMENT RESTRICTOR by Biodynamic Technologies, Inc.
- OSTEONICS SCREW HOLE PLUGS by Osteonics Corp.
- CEMENT RESTRICTOR by American Ortomed Corp.
- SCIENT'X CEMENT RESTRICTOR by Scient'X
- Mectaplug PE II by Medacta International S.A.