RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
FDA 510(k) clearance K142095 · decided 2014-10-15
Clearance details
- K-number
- K142095
- Device name
- RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
- Applicant
- Renovis Surgical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-01
- Decision date
- 2014-10-15
- Days to decision
- 75 days
- Clearance type
- Special
- Product code
- OVD
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Ashland, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.