510(k) K183228
K183228 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "HammerToe Compression System". The FDA issued a decision of Substantially Equivalent on Jan 25, 2019. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Paragon 28, Inc. has 59 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 25, 2019
- Date Received
- Nov 20, 2018
- 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
- 510(k)