510(k) clearance
Cerclage Cabling System
- 510(k) number
- K262960
- Applicant
- Pioneer Surgical Technology, Inc. dba EXALTA Group
- Decision date
- Oct 29, 2026
- Date received
- Aug 25, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- JDQ
- Device type
- Cerclage, Fixation
- Device class
- Class II
- Regulation
- 21 CFR 888.3010
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Marquette, MI, US