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FDA 510(k)

SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828

K-Number: K000616 · 2000-03-23

ApplicantBionx Implants, Ltd.
Decision Date2000-03-23
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 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 2000-03-23 under 510(k) number K000616. 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 SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828?

SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 is a medical device that received FDA 510(k) clearance on 2000-03-23. The listed applicant is Bionx Implants, Ltd.. The 510(k) number is K000616.

When did SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 receive FDA 510(k) clearance?

SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 received FDA 510(k) clearance on 2000-03-23, under 510(k) number K000616.

Who is the listed applicant for SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828?

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 SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828?

The FDA product code for SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 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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