510(k) K190166
K190166 is an FDA 510(k) premarket notification submitted by TriMed, Inc. for the device "TriMed Nitinol Staple System". The FDA issued a decision of Substantially Equivalent on Jul 1, 2019. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. TriMed, Inc. has 37 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 1, 2019
- Date Received
- Jan 31, 2019
- 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)