FDA 510(k)

ApolloKnee

K-Number: K231172 · 2023-07-26

Decision Date2023-07-26

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ApolloKnee is a medical device manufactured by Corin U.S.A. Limited. It received FDA 510(k) clearance on 2023-07-26 under approval number K231172. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ApolloKnee?

ApolloKnee is a medical device that received FDA 510(k) clearance on 2023-07-26. It is manufactured by Corin U.S.A. Limited. The 510(k) number is K231172.

When was ApolloKnee approved by the FDA?

ApolloKnee received FDA 510(k) clearance on 2023-07-26, under approval number K231172.

What company makes ApolloKnee?

ApolloKnee is manufactured by Corin U.S.A. Limited.

What is the FDA product code for ApolloKnee?

The FDA product code for ApolloKnee is OLO.

Other Devices by Corin U.S.A. Limited

K153772Corin TriFit TS Hip K153725Corin TaperFit Hip Stem K153381Corin Metafix Hip Stem K170359Trinity Dual Mobility System K170808Unity Total Knee System K162942Corin MetaFix Hip Stem

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Related Devices (Code: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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.