510(k) K190582
K190582 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "MicroLink All-Suture Button Fixation System (Radiopaque)". The FDA issued a decision of Substantially Equivalent on Jun 28, 2019. The device falls under product code HTN (Washer, Bolt Nut), a Class II device regulated under 21 CFR 888.3030. Conmed Corporation has 82 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 28, 2019
- Date Received
- Mar 6, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Washer, Bolt Nut
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)