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FDA 510(k)

Apollo Ankle Fracture Plating System

K-Number: K213005 · 2022-03-11

ApplicantGlw Medical, Inc.
Decision Date2022-03-11
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Apollo Ankle Fracture Plating System is a medical device manufactured by Glw Medical, Inc.. It received FDA 510(k) clearance on 2022-03-11 under approval number K213005. 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 Apollo Ankle Fracture Plating System?

Apollo Ankle Fracture Plating System is a medical device that received FDA 510(k) clearance on 2022-03-11. It is manufactured by Glw Medical, Inc.. The 510(k) number is K213005.

When was Apollo Ankle Fracture Plating System approved by the FDA?

Apollo Ankle Fracture Plating System received FDA 510(k) clearance on 2022-03-11, under approval number K213005.

What company makes Apollo Ankle Fracture Plating System?

Apollo Ankle Fracture Plating System is manufactured by Glw Medical, Inc..

What is the FDA product code for Apollo Ankle Fracture Plating System?

The FDA product code for Apollo Ankle Fracture Plating System is HRS.

Related Clinical Trials

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Related Devices (Code: HRS)

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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.

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