Quick-Start Screws
K-Number: K212547 · 2021-12-30
ApplicantInnovate Orthopaedics Limited
Decision Date2021-12-30
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Quick-Start Screws is a medical device manufactured by Innovate Orthopaedics Limited. It received FDA 510(k) clearance on 2021-12-30 under approval number K212547. 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 Quick-Start Screws?
Quick-Start Screws is a medical device that received FDA 510(k) clearance on 2021-12-30. It is manufactured by Innovate Orthopaedics Limited. The 510(k) number is K212547.
When was Quick-Start Screws approved by the FDA?
Quick-Start Screws received FDA 510(k) clearance on 2021-12-30, under approval number K212547.
What company makes Quick-Start Screws?
Quick-Start Screws is manufactured by Innovate Orthopaedics Limited.
What is the FDA product code for Quick-Start Screws?
The FDA product code for Quick-Start Screws is HWC. This falls under the Cardiovascular category.
Related Clinical Trials
Related PubMed Literature
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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.