SimpliFix Hip System
K-Number: K230053 · 2023-04-19
ApplicantStabiliz Orthopaedics, Inc.
Decision Date2023-04-19
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SimpliFix Hip System is a medical device manufactured by Stabiliz Orthopaedics, Inc.. It received FDA 510(k) clearance on 2023-04-19 under approval number K230053. 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 SimpliFix Hip System?
SimpliFix Hip System is a medical device that received FDA 510(k) clearance on 2023-04-19. It is manufactured by Stabiliz Orthopaedics, Inc.. The 510(k) number is K230053.
When was SimpliFix Hip System approved by the FDA?
SimpliFix Hip System received FDA 510(k) clearance on 2023-04-19, under approval number K230053.
What company makes SimpliFix Hip System?
SimpliFix Hip System is manufactured by Stabiliz Orthopaedics, Inc..
What is the FDA product code for SimpliFix Hip System?
The FDA product code for SimpliFix Hip 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.