K163181
Substantially EquivalentTRANSLACE Spinal Tethering System
- Applicant
- Medtronic Sofamor Danek USA, Inc.
- Product code
- OWI
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Memphis, TN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.