Cd Horizon Spinal System
by Medtronic Sofamor Danek, Inc. 2 variants
510(k) K082236
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number00613994484093 | Date17 Jul 2015 | StatusListed |
| United States | FDA 510(k)SESE 510(k) | NumberK082236 | Date10 Oct 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile
- Model / Reference
- X0508130
- FDA applicant
- Medtronic Sofamor Danek
- Primary DI / UDI-DI
- 00613994484093
- 510(k) Number
- FDA Product Code
- NKB, NQP, MNH, MNI, KWQ, KWP
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3070 510(k)GUDID888.3060 GUDID888.3050 GUDID
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
- GUDID distribution status
- Not in Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
- Size
- Length — 75.0 Millimeter
Other devices from Medtronic Sofamor Danek, Inc.
Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No