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FDA 510(k)

CONTOUR LABRAL NAIL, MODEL 533520A

K-Number: K003970 · 2001-01-12

ApplicantBionx Implants, Inc.
Decision Date2001-01-12
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONTOUR LABRAL NAIL, MODEL 533520A is the device name listed in this FDA 510(k) record. The listed applicant is Bionx Implants, Inc.. It received FDA 510(k) clearance on 2001-01-12 under 510(k) number K003970. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTOUR LABRAL NAIL, MODEL 533520A?

CONTOUR LABRAL NAIL, MODEL 533520A is a medical device that received FDA 510(k) clearance on 2001-01-12. The listed applicant is Bionx Implants, Inc.. The 510(k) number is K003970.

When did CONTOUR LABRAL NAIL, MODEL 533520A receive FDA 510(k) clearance?

CONTOUR LABRAL NAIL, MODEL 533520A received FDA 510(k) clearance on 2001-01-12, under 510(k) number K003970.

Who is the listed applicant for CONTOUR LABRAL NAIL, MODEL 533520A?

The FDA 510(k) record lists Bionx Implants, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTOUR LABRAL NAIL, MODEL 533520A?

The FDA product code for CONTOUR LABRAL NAIL, MODEL 533520A is MAI.

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Official Source

View on FDA Database →

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

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