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FDA 510(k)

ANATOMICAL BANKART TACK, MODEL 523520A

K-Number: K992567 · 1999-08-27

ApplicantBionx Implants, Ltd.
Decision Date1999-08-27
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANATOMICAL BANKART TACK, MODEL 523520A 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 1999-08-27 under 510(k) number K992567. 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 ANATOMICAL BANKART TACK, MODEL 523520A?

ANATOMICAL BANKART TACK, MODEL 523520A is a medical device that received FDA 510(k) clearance on 1999-08-27. The listed applicant is Bionx Implants, Ltd.. The 510(k) number is K992567.

When did ANATOMICAL BANKART TACK, MODEL 523520A receive FDA 510(k) clearance?

ANATOMICAL BANKART TACK, MODEL 523520A received FDA 510(k) clearance on 1999-08-27, under 510(k) number K992567.

Who is the listed applicant for ANATOMICAL BANKART TACK, MODEL 523520A?

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 ANATOMICAL BANKART TACK, MODEL 523520A?

The FDA product code for ANATOMICAL BANKART TACK, MODEL 523520A 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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