510(k) K180582
K180582 is an FDA 510(k) premarket notification submitted by A & E Medical Corporation for the device "Sternal Cable System". The FDA issued a decision of Substantially Equivalent on May 31, 2018. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. A & E Medical Corporation has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2018
- Date Received
- March 5, 2018
- Clearance Type
- Traditional
- 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