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FDA 510(k)

MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR

K-Number: K060693 · 2006-06-06

ApplicantArthrotek, Inc.
Decision Date2006-06-06
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Arthrotek, Inc.. It received FDA 510(k) clearance on 2006-06-06 under 510(k) number K060693. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR?

MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2006-06-06. The listed applicant is Arthrotek, Inc.. The 510(k) number is K060693.

When did MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR receive FDA 510(k) clearance?

MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR received FDA 510(k) clearance on 2006-06-06, under 510(k) number K060693.

Who is the listed applicant for MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR?

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 MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR?

The FDA product code for MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR is HWC. This falls under the Cardiovascular category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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