510(k) K172921
K172921 is an FDA 510(k) premarket notification submitted by Stryker for the device "Stryker Self-Punching ICONIX". The FDA issued a decision of Substantially Equivalent on Nov 20, 2017. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Stryker has 270 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 20, 2017
- Date Received
- Sep 25, 2017
- 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)