Normandy VBR System
FDA 510(k) clearance K180673 · decided 2018-07-13
Clearance details
- K-number
- K180673
- Device name
- Normandy VBR System
- Applicant
- Zavation Medical Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-03-14
- Decision date
- 2018-07-13
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- PLR
- Device class
- 2
- Regulation number
- 888.3060
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Flowood, MS, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.