510(k) K162429
K162429 is an FDA 510(k) premarket notification submitted by Ziptek, LLC for the device "ZipE Knotless Tissue Repair and Attachment Devices". The FDA issued a decision of Substantially Equivalent on Mar 13, 2017. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 13, 2017
- Date Received
- Aug 30, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fastener, Fixation, Biodegradable, Soft Tissue
- Device Class
- Class II
- Regulation Number
- 888.3030
- Review Panel
- OR
- Submission Type
- 510(k)