FDA 510(k)

ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)

K-Number: K052630 · 2005-10-17

ApplicantDepuy Mitek, A Johnson & Johnson Company

Decision Date2005-10-17

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. It received FDA 510(k) clearance on 2005-10-17 under 510(k) number K052630. 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 ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)?

ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. The 510(k) number is K052630.

When did ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) receive FDA 510(k) clearance?

ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) received FDA 510(k) clearance on 2005-10-17, under 510(k) number K052630.

Who is the listed applicant for ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)?

The FDA 510(k) record lists Depuy Mitek, A Johnson & Johnson Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)?

The FDA product code for ROTATOR CUFF QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE) 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.