Biomet Variable Pitch Compression Screw System
K-Number: K160058 · 2016-03-09
ApplicantBiomet, Inc.
Decision Date2016-03-09
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Biomet Variable Pitch Compression Screw System is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2016-03-09 under approval number K160058. 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 Biomet Variable Pitch Compression Screw System?
Biomet Variable Pitch Compression Screw System is a medical device that received FDA 510(k) clearance on 2016-03-09. It is manufactured by Biomet, Inc.. The 510(k) number is K160058.
When was Biomet Variable Pitch Compression Screw System approved by the FDA?
Biomet Variable Pitch Compression Screw System received FDA 510(k) clearance on 2016-03-09, under approval number K160058.
What company makes Biomet Variable Pitch Compression Screw System?
Biomet Variable Pitch Compression Screw System is manufactured by Biomet, Inc..
What is the FDA product code for Biomet Variable Pitch Compression Screw System?
The FDA product code for Biomet Variable Pitch Compression Screw 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.