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FDA 510(k)

Cannulated Screw Internal Fixation System

K-Number: K173286 · 2017-12-14

ApplicantLife Spine, Inc.
Decision Date2017-12-14
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Cannulated Screw Internal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2017-12-14 under 510(k) number K173286. 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 Cannulated Screw Internal Fixation System?

Cannulated Screw Internal Fixation System is a medical device that received FDA 510(k) clearance on 2017-12-14. The listed applicant is Life Spine, Inc.. The 510(k) number is K173286.

When did Cannulated Screw Internal Fixation System receive FDA 510(k) clearance?

Cannulated Screw Internal Fixation System received FDA 510(k) clearance on 2017-12-14, under 510(k) number K173286.

Who is the listed applicant for Cannulated Screw Internal Fixation System?

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

What is the FDA product code for Cannulated Screw Internal Fixation System?

The FDA product code for Cannulated Screw Internal Fixation System 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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