510(k) K170923
K170923 is an FDA 510(k) premarket notification submitted by Paragon 28 for the device "JAWS(TM) Nitinol Staple System". The FDA issued a decision of Substantially Equivalent on Jul 24, 2017. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Paragon 28 has 59 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 2017
- Date Received
- Mar 29, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Fixation, Bone
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)