X-STOP IPD SYSTEM
FDA premarket approval P040001/S003 · decided 2006-10-19
Approval details
- PMA number
- P040001
- Supplement
- S003
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- X-STOP IPD SYSTEM
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Medtronic Sofamor Danek, Inc.
- Date received
- 2006-09-19
- Decision date
- 2006-10-19
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- CHANGES IN PACKAGING FOOTPRINT, PACKAGING PROCESSES, LABELING PROCESSES AND MANUFACTURING FLOW FOR THE DEVICE.
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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 |