X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM
FDA premarket approval P040001/S012 · decided 2010-01-28
Approval details
- PMA number
- P040001
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM
- Generic name
- Prosthesis, spinous process spacer/plate
- Applicant
- Medtronic Sofamor Danek, Inc.
- Date received
- 2009-02-09
- Decision date
- 2010-01-28
- Days to decision
- 353 days
- Decision code
- APPR
- Product code
- NQO
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Memphis, TN
- Statement
- APPROVAL FOR A LABELING CHANGE TO ADD PLACEMENT OF THE PATIENT IN THE PRONE POSITION DURING IMPLANTATION OF THE DEVICE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |