Expedium Spine System, VIPER and VIPER 2 Systems
FDA 510(k) clearance K160904 · decided 2016-07-01
Clearance details
- K-number
- K160904
- Device name
- Expedium Spine System, VIPER and VIPER 2 Systems
- Applicant
- Medos International SARL
- Decision
- Substantially Equivalent
- Date received
- 2016-04-01
- Decision date
- 2016-07-01
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Le Locle, CH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.