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FDA 510(k)

KLS Martin Cannulated Headless Screws

K-Number: K161259 · 2016-12-19

ApplicantKLS Martin L.P.
Decision Date2016-12-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KLS Martin Cannulated Headless Screws is a medical device manufactured by KLS Martin L.P.. It received FDA 510(k) clearance on 2016-12-19 under approval number K161259. 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 KLS Martin Cannulated Headless Screws?

KLS Martin Cannulated Headless Screws is a medical device that received FDA 510(k) clearance on 2016-12-19. It is manufactured by KLS Martin L.P.. The 510(k) number is K161259.

When was KLS Martin Cannulated Headless Screws approved by the FDA?

KLS Martin Cannulated Headless Screws received FDA 510(k) clearance on 2016-12-19, under approval number K161259.

What company makes KLS Martin Cannulated Headless Screws?

KLS Martin Cannulated Headless Screws is manufactured by KLS Martin L.P..

What is the FDA product code for KLS Martin Cannulated Headless Screws?

The FDA product code for KLS Martin Cannulated Headless Screws is HWC. This falls under the Cardiovascular category.

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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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