FIGURE 8 STERNOTOMY CLOSURE DEVICE— 510(k) K110541

Name: FDA 510(k) clearance K110541
Creator: U.S. Food and Drug Administration
Published: 2011-07-06

Substantially Equivalent

Figure 8 Surgical, Incorporated

FDA 510(k) clearance K110541 for FIGURE 8 STERNOTOMY CLOSURE DEVICE, Substantially Equivalent on 2011-07-06. Applicant: Figure 8 Surgical, Incorporated. Device class: 2.

Clearance details

Applicant: Figure 8 Surgical, Incorporated
Product code: Code JDQ
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2011-02-25
Decision date: 2011-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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Adverse events under product code JDQ

product code JDQ

Death: 9
Injury: 330
Total: 339

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.