MODIFICATION TO CD HORIZON SPINAL SYSTEM
FDA 510(k) clearance K042025 · decided 2004-08-25
Clearance details
- K-number
- K042025
- Device name
- MODIFICATION TO CD HORIZON SPINAL SYSTEM
- Applicant
- Medtronic Sofamor Danek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-07-28
- Decision date
- 2004-08-25
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- KWQ
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5 recall (Z-0464-2012) | Medtronic Sofamor Danek USA Inc | 2012-01-11 |
| CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm recall (Z-0465-2012) | Medtronic Sofamor Danek USA Inc | 2012-01-11 |
| CD HORIZON (R) LEGACY (TM) MAS, REF 75445540, pedicle screw, Rx only, Medtronic Sofamor Da recall (Z-2875-2011) | Medtronic Sofamor Danek USA Inc | 2011-07-25 |
| ATLANTIS (R) Self-Tapping Variable Angle Screw, Rx only, Medtronic Sofamor Danek USA, 1800 recall (Z-2878-2011) | Medtronic Sofamor Danek USA Inc | 2011-07-25 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| PRESTIGE CERVICAL DISC SYSTEM (P060018/S005) | Medtronic Sofamor Danek, Inc. | 2016-08-11 |
| PRESTIGE® Cervical Disc (P060018/S004) | Medtronic Sofamor Danek, Inc. | 2016-07-20 |
| X-STOP LTOS (P040001/S021) | Medtronic Sofamor Danek, Inc. | 2014-12-12 |
| X-STOP PEEK INTERSPINOUS PROCESS DECOMPRESSION SYSTEM/ INTERSPINOUS SPACER SYSTEM (P040001/S022) | Medtronic Sofamor Danek, Inc. | 2014-10-24 |
| PRESTIGE CERVICAL DISC (P060018/S003) | Medtronic Sofamor Danek, Inc. | 2013-07-12 |
| X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S020) | Medtronic Sofamor Danek, Inc. | 2012-07-25 |
| X-STOP INTERSPINOUS SPACER SYSTEM (P040001/S019) | Medtronic Sofamor Danek, Inc. | 2011-05-04 |
| PRESTIGE CERVICAL DISC (P060018/S002) | Medtronic Sofamor Danek, Inc. | 2011-03-24 |