CONCORDE LIFT
FDA 510(k) clearance K171425 · decided 2017-07-20
Clearance details
- K-number
- K171425
- Device name
- CONCORDE LIFT
- Applicant
- Medos International SARL
- Decision
- Substantially Equivalent
- Date received
- 2017-05-15
- Decision date
- 2017-07-20
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Lelocle, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C) recall (Z-1225-2019) | DePuy Spine, Inc. | 2019-04-27 |