MOUNTAINEER LAMINOPLASTY SYSTEM
FDA 510(k) clearance K091994 · decided 2010-01-07
Clearance details
- K-number
- K091994
- Device name
- MOUNTAINEER LAMINOPLASTY SYSTEM
- Applicant
- Depuy Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-02
- Decision date
- 2010-01-07
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- NQW
- Device class
- 2
- Regulation number
- 888.3050
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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| Hinged Laminoplasty System (K191927) | Life Spine, Inc. | 2019-09-20 |
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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 |