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FDA 510(k)

MENISCUS ARROW, MODELS 531110, 531113, 531116

K-Number: K993453 · 1999-11-09

ApplicantBionx Implants, Ltd.
Decision Date1999-11-09
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MENISCUS ARROW, MODELS 531110, 531113, 531116 is the device name listed in this FDA 510(k) record. The listed applicant is Bionx Implants, Ltd.. It received FDA 510(k) clearance on 1999-11-09 under 510(k) number K993453. 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 MENISCUS ARROW, MODELS 531110, 531113, 531116?

MENISCUS ARROW, MODELS 531110, 531113, 531116 is a medical device that received FDA 510(k) clearance on 1999-11-09. The listed applicant is Bionx Implants, Ltd.. The 510(k) number is K993453.

When did MENISCUS ARROW, MODELS 531110, 531113, 531116 receive FDA 510(k) clearance?

MENISCUS ARROW, MODELS 531110, 531113, 531116 received FDA 510(k) clearance on 1999-11-09, under 510(k) number K993453.

Who is the listed applicant for MENISCUS ARROW, MODELS 531110, 531113, 531116?

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

What is the FDA product code for MENISCUS ARROW, MODELS 531110, 531113, 531116?

The FDA product code for MENISCUS ARROW, MODELS 531110, 531113, 531116 is MAI.

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Other records listing Bionx Implants, Ltd. as applicant

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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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