X-STOP INTERSPINOUS SPACER SYSTEM
FDA premarket approval P040001/S015 · decided 2009-10-21
Approval details
- PMA number
- P040001
- Supplement
- S015
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- X-STOP INTERSPINOUS SPACER SYSTEM
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Medtronic Sofamor Danek, Inc.
- Date received
- 2009-09-24
- Decision date
- 2009-10-21
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR CHANGES TO THE DEVICE NAME, INSTRUCTIONS FOR USE, AND PHYSICIAN¿S AND PATIENT¿S GUIDES.
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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 |