CINCH BONE ANCHOR SYSTEM— 510(k) K062739

Substantially Equivalent

Sapphire Medical, Inc.

FDA 510(k) clearance K062739 for CINCH BONE ANCHOR SYSTEM, Substantially Equivalent on 2007-02-13. Applicant: Sapphire Medical, Inc..

Clearance details

Applicant: Sapphire Medical, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2006-09-13
Decision date: 2007-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.