FDA 510(k)

FIGURE 8 STERNOTOMY CLOSURE DEVICE

K-Number: K110541 · 2011-07-06

ApplicantFigure 8 Surgical, Incorporated

Decision Date2011-07-06

Product CodeJDQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FIGURE 8 STERNOTOMY CLOSURE DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Figure 8 Surgical, Incorporated. It received FDA 510(k) clearance on 2011-07-06 under 510(k) number K110541. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIGURE 8 STERNOTOMY CLOSURE DEVICE?

FIGURE 8 STERNOTOMY CLOSURE DEVICE is a medical device that received FDA 510(k) clearance on 2011-07-06. The listed applicant is Figure 8 Surgical, Incorporated. The 510(k) number is K110541.

When did FIGURE 8 STERNOTOMY CLOSURE DEVICE receive FDA 510(k) clearance?

FIGURE 8 STERNOTOMY CLOSURE DEVICE received FDA 510(k) clearance on 2011-07-06, under 510(k) number K110541.

Who is the listed applicant for FIGURE 8 STERNOTOMY CLOSURE DEVICE?

The FDA 510(k) record lists Figure 8 Surgical, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIGURE 8 STERNOTOMY CLOSURE DEVICE?

The FDA product code for FIGURE 8 STERNOTOMY CLOSURE DEVICE is JDQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.