X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
FDA premarket approval P040001/S007 · decided 2007-10-04
Approval details
- PMA number
- P040001
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Medtronic Sofamor Danek, Inc.
- Date received
- 2007-06-06
- Decision date
- 2007-10-04
- Days to decision
- 120 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR A MODIFIED VERSION OF THE TISSUE EXPANDER OF THE TITANIUM VERSION OF THE X-STOP SPACER ASSEMBLY.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (K251193) | Medtronic Sofamor Danek, Inc. | 2025-06-12 |
| Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granules (K243706) | Medtronic Sofamor Danek, Inc. | 2025-01-17 |
| Robotic Graft Delivery Instruments (K230716) | Medtronic Sofamor Danek, Inc. | 2023-07-18 |
| MASTERGRAFT MATRIX EXT; MASTERGRAFT PUTTY, MASTERGRAFT STRIP (K141824) | Medtronic Sofamor Danek, Inc. | 2014-09-05 |
| DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM (K140417) | Medtronic Sofamor Danek, Inc. | 2014-07-09 |
| CD HORIZON SPINAL SYSTEM (K140449) | Medtronic Sofamor Danek, Inc. | 2014-03-25 |
| CLYDESDALE SPINAL SYSTEM (K132897) | Medtronic Sofamor Danek, Inc. | 2013-12-11 |
| CRESCENT SPINAL SYSTEM (K133216) | Medtronic Sofamor Danek, Inc. | 2013-11-22 |