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FDA 510(k)

BIORIGID NAIL TIBIA

K-Number: K970013 · 1997-03-13

ApplicantAap GmbH and Co. Betriebs KG
Decision Date1997-03-13
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIORIGID NAIL TIBIA is the device name listed in this FDA 510(k) record. The listed applicant is Aap GmbH and Co. Betriebs KG. It received FDA 510(k) clearance on 1997-03-13 under 510(k) number K970013. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIORIGID NAIL TIBIA?

BIORIGID NAIL TIBIA is a medical device that received FDA 510(k) clearance on 1997-03-13. The listed applicant is Aap GmbH and Co. Betriebs KG. The 510(k) number is K970013.

When did BIORIGID NAIL TIBIA receive FDA 510(k) clearance?

BIORIGID NAIL TIBIA received FDA 510(k) clearance on 1997-03-13, under 510(k) number K970013.

Who is the listed applicant for BIORIGID NAIL TIBIA?

The FDA 510(k) record lists Aap GmbH and Co. Betriebs KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIORIGID NAIL TIBIA?

The FDA product code for BIORIGID NAIL TIBIA is HTY.

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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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