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FDA 510(k)

CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116

K-Number: K012334 · 2001-09-19

ApplicantBionx Implants, Inc.
Decision Date2001-09-19
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 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 2001-09-19 under 510(k) number K012334. 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 MENISCUS ARROW, MODELS 541110, 541113, AND 541116?

CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 is a medical device that received FDA 510(k) clearance on 2001-09-19. The listed applicant is Bionx Implants, Inc.. The 510(k) number is K012334.

When did CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 receive FDA 510(k) clearance?

CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 received FDA 510(k) clearance on 2001-09-19, under 510(k) number K012334.

Who is the listed applicant for CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116?

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 MENISCUS ARROW, MODELS 541110, 541113, AND 541116?

The FDA product code for CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 is MAI.

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Other records listing Bionx Implants, Inc. as applicant

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Related Devices (Code: 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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