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FDA 510(k)

MINI CANNULATED HEADED AND HEADLESS SCREW SET

K-Number: K120493 · 2012-05-17

ApplicantInstratek, Inc.
Decision Date2012-05-17
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MINI CANNULATED HEADED AND HEADLESS SCREW SET is the device name listed in this FDA 510(k) record. The listed applicant is Instratek, Inc.. It received FDA 510(k) clearance on 2012-05-17 under 510(k) number K120493. 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 MINI CANNULATED HEADED AND HEADLESS SCREW SET?

MINI CANNULATED HEADED AND HEADLESS SCREW SET is a medical device that received FDA 510(k) clearance on 2012-05-17. The listed applicant is Instratek, Inc.. The 510(k) number is K120493.

When did MINI CANNULATED HEADED AND HEADLESS SCREW SET receive FDA 510(k) clearance?

MINI CANNULATED HEADED AND HEADLESS SCREW SET received FDA 510(k) clearance on 2012-05-17, under 510(k) number K120493.

Who is the listed applicant for MINI CANNULATED HEADED AND HEADLESS SCREW SET?

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

What is the FDA product code for MINI CANNULATED HEADED AND HEADLESS SCREW SET?

The FDA product code for MINI CANNULATED HEADED AND HEADLESS SCREW SET is HWC. This falls under the Cardiovascular category.

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Official Source

View on FDA Database →

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