510(k) K112097— GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
Substantially EquivalentExactech, Inc.
Clearance details
- Applicant
- Exactech, Inc.
- Product code
- Code MRW
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gainesville, FL, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.