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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Stabiliz Orthopaedics, Inc.. It received FDA 510(k) clearance on 2023-04-19 under 510(k) 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. The listed applicant is Stabiliz Orthopaedics, Inc.. The 510(k) number is K230053.

When did SimpliFix Hip System receive FDA 510(k) clearance?

SimpliFix Hip System received FDA 510(k) clearance on 2023-04-19, under 510(k) number K230053.

Who is the listed applicant for SimpliFix Hip System?

The FDA 510(k) record lists Stabiliz Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Stabiliz Orthopaedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260112QuikFix External Fixator: Knee-Spanning Pack

Related Devices (Code: HWC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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