510(k) K262960
K262960 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc. Dba EXALTA Group for the device "Cerclage Cabling System". The FDA issued a decision of Substantially Equivalent on Oct 29, 2026. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 29, 2026
- Date Received
- Aug 25, 2026
- 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
- 510(k)