MODIFICATION TO EXPEDIUM SPINE SYSTEM
FDA 510(k) clearance K062174 · decided 2006-11-02
Clearance details
- K-number
- K062174
- Device name
- MODIFICATION TO EXPEDIUM SPINE SYSTEM
- Applicant
- Depuy Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-31
- Decision date
- 2006-11-02
- Days to decision
- 94 days
- Clearance type
- Special
- Product code
- MNH
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Reliance Spinal Screw System (K162066) | Reliance Medical Systems, LLC | 2016-12-02 |
| CastleLoc Spinal Fixation System (K162801) | L&K BIOMED Co., Ltd. | 2016-11-03 |
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| HC Spinal System (K151362) | Hung Chun Bio-S Co., Ltd. | 2016-05-05 |
| Zavation Spinal System (K153404) | Zavation, LLC | 2016-04-21 |
| Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System (K160020) | Captiva Spine | 2016-03-02 |
| Spinal Inner Fixation System (K143013) | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015-12-11 |
| Romeo posterior osteosynthesis system (K151695) | Spineart | 2015-09-10 |
| CapLOX II/TowerLOX Pedicle Screw System (K151116) | Captiva Spine | 2015-06-26 |
| Republic Spine Dark Star Spinal System (K150283) | Republic Spine, LLC | 2015-04-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| IN MOTION LUMBAR ARTIFICIAL DISC (P040006/S005) | Depuy Spine, Inc. | 2011-02-08 |
| IN MOTION ARTIFICIAL DISC (P040006/S004) | Depuy Spine, Inc. | 2007-09-05 |
| CHARITE ARTIFICIAL DISC (P040006/S003) | Depuy Spine, Inc. | 2006-12-15 |
| CHARITE ARTIFICIAL DISC (P040006/S002) | Depuy Spine, Inc. | 2006-03-29 |
| CHARITE ARTIFICIAL DISC (P040006/S001) | Depuy Spine, Inc. | 2005-06-16 |
| CHARITE ARTIFICIAL DISC (P040006) | Depuy Spine, Inc. | 2004-10-26 |
| LUMBAR I/F CAGE SYSTEM (P960025/S010) | Depuy Spine, Inc. | 2004-03-17 |
| SABER LUMBAR I/F CAGE, JAGUAR LUMBAR I/F CAGE (P960025/S011) | Depuy Spine, Inc. | 2004-03-05 |