510(k) K103623
K103623 is an FDA 510(k) premarket notification submitted by Newdeal Sas for the device "NEWDEAL INTERPHALANGEAL IMPLANT". The FDA issued a decision of Substantially Equivalent on March 20, 2012. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Newdeal Sas has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2012
- Date Received
- December 10, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Fixation, Smooth
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type