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FDA 510(k)

Biomet Headless Compression and Twist-Off Screws

K-Number: K190035 · 2019-02-07

ApplicantBiomet, Inc.
Decision Date2019-02-07
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Biomet Headless Compression and Twist-Off Screws is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2019-02-07 under approval number K190035. 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 Headless Compression and Twist-Off Screws?

Biomet Headless Compression and Twist-Off Screws is a medical device that received FDA 510(k) clearance on 2019-02-07. It is manufactured by Biomet, Inc.. The 510(k) number is K190035.

When was Biomet Headless Compression and Twist-Off Screws approved by the FDA?

Biomet Headless Compression and Twist-Off Screws received FDA 510(k) clearance on 2019-02-07, under approval number K190035.

What company makes Biomet Headless Compression and Twist-Off Screws?

Biomet Headless Compression and Twist-Off Screws is manufactured by Biomet, Inc..

What is the FDA product code for Biomet Headless Compression and Twist-Off Screws?

The FDA product code for Biomet Headless Compression and Twist-Off Screws is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING

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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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