Forma Medical Headless Compression Screw
K-Number: K230945 · 2023-07-18
ApplicantForma Medical, Inc.
Decision Date2023-07-18
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Forma Medical Headless Compression Screw is a medical device manufactured by Forma Medical, Inc.. It received FDA 510(k) clearance on 2023-07-18 under approval number K230945. 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 Forma Medical Headless Compression Screw?
Forma Medical Headless Compression Screw is a medical device that received FDA 510(k) clearance on 2023-07-18. It is manufactured by Forma Medical, Inc.. The 510(k) number is K230945.
When was Forma Medical Headless Compression Screw approved by the FDA?
Forma Medical Headless Compression Screw received FDA 510(k) clearance on 2023-07-18, under approval number K230945.
What company makes Forma Medical Headless Compression Screw?
Forma Medical Headless Compression Screw is manufactured by Forma Medical, Inc..
What is the FDA product code for Forma Medical Headless Compression Screw?
The FDA product code for Forma Medical Headless Compression Screw 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.