FDA 510(k)

SkyOPS Orthopedic Plate System

K-Number: K233154 · 2023-12-21

Decision Date2023-12-21

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SkyOPS Orthopedic Plate System is a medical device manufactured by Sky Surgical, LLC. It received FDA 510(k) clearance on 2023-12-21 under approval number K233154. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SkyOPS Orthopedic Plate System?

SkyOPS Orthopedic Plate System is a medical device that received FDA 510(k) clearance on 2023-12-21. It is manufactured by Sky Surgical, LLC. The 510(k) number is K233154.

When was SkyOPS Orthopedic Plate System approved by the FDA?

SkyOPS Orthopedic Plate System received FDA 510(k) clearance on 2023-12-21, under approval number K233154.

What company makes SkyOPS Orthopedic Plate System?

SkyOPS Orthopedic Plate System is manufactured by Sky Surgical, LLC.

What is the FDA product code for SkyOPS Orthopedic Plate System?

The FDA product code for SkyOPS Orthopedic Plate System is HRS.

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Related PubMed Literature

PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

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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.