510(k) K121575
K121575 is an FDA 510(k) premarket notification submitted by Ortho Solutions Limited for the device "OXFORD ANKLE FUSION NAIL(AFN) SYSTEM". The FDA issued a decision of Substantially Equivalent on September 14, 2012. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Ortho Solutions Limited has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 2012
- Date Received
- May 30, 2012
- 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