510(k) K912420
K912420 is an FDA 510(k) premarket notification submitted by Scientific Research for the device "ORTHOFIX UNREAMED TIBIAL NAIL SYSTEM". The FDA issued a decision of Substantially Equivalent on September 23, 1991. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Scientific Research has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1991
- Date Received
- May 31, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Rod, Fixation, Intramedullary And Accessories
- Device Class
- Class II
- Regulation Number
- 888.3020
- Review Panel
- OR
- Submission Type