510(k) K261271

Cable-Ready® Cable Grip System by Pioneer Surgical Technology, Inc. — Product Code JDQ

K261271 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc. for the device "Cable-Ready® Cable Grip System". The FDA issued a decision of Substantially Equivalent on July 16, 2026. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Pioneer Surgical Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2026
Date Received
April 17, 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