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FDA 510(k)

ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE

K-Number: K061776 · 2006-09-25

ApplicantArthrotek, Inc.
Decision Date2006-09-25
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Arthrotek, Inc.. It received FDA 510(k) clearance on 2006-09-25 under 510(k) number K061776. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE?

ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE is a medical device that received FDA 510(k) clearance on 2006-09-25. The listed applicant is Arthrotek, Inc.. The 510(k) number is K061776.

When did ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE receive FDA 510(k) clearance?

ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE received FDA 510(k) clearance on 2006-09-25, under 510(k) number K061776.

Who is the listed applicant for ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE?

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

What is the FDA product code for ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE?

The FDA product code for ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICE is JDR.

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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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