510(k) K180960
K180960 is an FDA 510(k) premarket notification submitted by S.B.M. Sas Sciences For Bio Materials for the device "FIXIT / ComposiTCP Threaded Anchor System". The FDA issued a decision of Substantially Equivalent on Jul 25, 2018. 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
- Jul 25, 2018
- Date Received
- Apr 12, 2018
- Clearance Type
- Special
- 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)