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FDA 510(k)

TRACER DYNAMIC AXIAL FIXATION

K-Number: K892638 · 1989-08-11

ApplicantTracer Medical
Decision Date1989-08-11
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRACER DYNAMIC AXIAL FIXATION is the device name listed in this FDA 510(k) record. The listed applicant is Tracer Medical. It received FDA 510(k) clearance on 1989-08-11 under 510(k) number K892638. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACER DYNAMIC AXIAL FIXATION?

TRACER DYNAMIC AXIAL FIXATION is a medical device that received FDA 510(k) clearance on 1989-08-11. The listed applicant is Tracer Medical. The 510(k) number is K892638.

When did TRACER DYNAMIC AXIAL FIXATION receive FDA 510(k) clearance?

TRACER DYNAMIC AXIAL FIXATION received FDA 510(k) clearance on 1989-08-11, under 510(k) number K892638.

Who is the listed applicant for TRACER DYNAMIC AXIAL FIXATION?

The FDA 510(k) record lists Tracer Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRACER DYNAMIC AXIAL FIXATION?

The FDA product code for TRACER DYNAMIC AXIAL FIXATION is JEC.

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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.

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