SPINESMITH CYNCH SPINAL SYSTEM
FDA 510(k) clearance K101085 · decided 2010-07-01
Clearance details
- K-number
- K101085
- Device name
- SPINESMITH CYNCH SPINAL SYSTEM
- Applicant
- Spine Smith Partners L.P.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-19
- Decision date
- 2010-07-01
- Days to decision
- 73 days
- Clearance type
- Special
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with recall (Z-0932-2013) | Spine Smith Partners LP | 2013-03-10 |