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FDA 510(k)

FIXATION STYLETS, MODELS 335-287 AND 335-288

K-Number: K000366 · 2000-04-14

ApplicantAccufix Research Institute
Decision Date2000-04-14
Product CodeDRB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FIXATION STYLETS, MODELS 335-287 AND 335-288 is the device name listed in this FDA 510(k) record. The listed applicant is Accufix Research Institute. It received FDA 510(k) clearance on 2000-04-14 under 510(k) number K000366. The device is classified under product code DRB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXATION STYLETS, MODELS 335-287 AND 335-288?

FIXATION STYLETS, MODELS 335-287 AND 335-288 is a medical device that received FDA 510(k) clearance on 2000-04-14. The listed applicant is Accufix Research Institute. The 510(k) number is K000366.

When did FIXATION STYLETS, MODELS 335-287 AND 335-288 receive FDA 510(k) clearance?

FIXATION STYLETS, MODELS 335-287 AND 335-288 received FDA 510(k) clearance on 2000-04-14, under 510(k) number K000366.

Who is the listed applicant for FIXATION STYLETS, MODELS 335-287 AND 335-288?

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

What is the FDA product code for FIXATION STYLETS, MODELS 335-287 AND 335-288?

The FDA product code for FIXATION STYLETS, MODELS 335-287 AND 335-288 is DRB.

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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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