510(k) K181749
K181749 is an FDA 510(k) premarket notification submitted by Kinamed, Incorporated for the device "SuperCable® Iso-Elastic Cerclage System". The FDA issued a decision of Substantially Equivalent on August 1, 2018. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Kinamed, Incorporated has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 2018
- Date Received
- July 2, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cerclage, Fixation
- Device Class
- Class II
- Regulation Number
- 888.3010
- Review Panel
- OR
- Submission Type