FDA 510(k)

VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819

K-Number: K100532 · 2010-03-17

ApplicantDepuy Mitek, A Johnson & Johnson Company

Decision Date2010-03-17

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 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 2010-03-17 under 510(k) number K100532. 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 VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819?

VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 is a medical device that received FDA 510(k) clearance on 2010-03-17. The listed applicant is Depuy Mitek, A Johnson & Johnson Company. The 510(k) number is K100532.

When did VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 receive FDA 510(k) clearance?

VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 received FDA 510(k) clearance on 2010-03-17, under 510(k) number K100532.

Who is the listed applicant for VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819?

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 VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819?

The FDA product code for VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 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.