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FDA 510(k)

BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM

K-Number: K013672 · 2002-04-08

ApplicantAzary Technologies, LLC
Decision Date2002-04-08
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Azary Technologies, LLC. It received FDA 510(k) clearance on 2002-04-08 under 510(k) number K013672. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM?

BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM is a medical device that received FDA 510(k) clearance on 2002-04-08. The listed applicant is Azary Technologies, LLC. The 510(k) number is K013672.

When did BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM receive FDA 510(k) clearance?

BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM received FDA 510(k) clearance on 2002-04-08, under 510(k) number K013672.

Who is the listed applicant for BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM?

The FDA 510(k) record lists Azary Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM?

The FDA product code for BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM is JEY.

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Related Devices (Code: JEY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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