510(k) K091788
K091788 is an FDA 510(k) premarket notification submitted by Newdeal Sas for the device "PANTA NAIL (DIA. 10MM), PANTA NAIL XL". The FDA issued a decision of Substantially Equivalent on July 29, 2009. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Newdeal Sas has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 29, 2009
- Date Received
- June 17, 2009
- Clearance Type
- Special
- 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