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FDA 510(k)

BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736

K-Number: K001378 · 2000-07-28

ApplicantBionx Implants, Inc.
Decision Date2000-07-28
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736 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 2000-07-28 under 510(k) number K001378. 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 BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736?

BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736 is a medical device that received FDA 510(k) clearance on 2000-07-28. The listed applicant is Bionx Implants, Inc.. The 510(k) number is K001378.

When did BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736 receive FDA 510(k) clearance?

BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736 received FDA 510(k) clearance on 2000-07-28, under 510(k) number K001378.

Who is the listed applicant for BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736?

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 BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736?

The FDA product code for BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736 is MAI.

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Other records listing Bionx Implants, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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