510(k) K203385
K203385 is an FDA 510(k) premarket notification submitted by Paragon 28, Inc. for the device "TenoTac Soft Tissue Fixation System". The FDA issued a decision of Substantially Equivalent on Feb 11, 2021. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), 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
- Feb 11, 2021
- Date Received
- Nov 18, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)