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FDA 510(k)

ApolloKnee

K-Number: K231172 · 2023-07-26

ApplicantCorin U.S.A. Limited
Decision Date2023-07-26
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ApolloKnee is the device name listed in this FDA 510(k) record. The listed applicant is Corin U.S.A. Limited. It received FDA 510(k) clearance on 2023-07-26 under 510(k) 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. The listed applicant is Corin U.S.A. Limited. The 510(k) number is K231172.

When did ApolloKnee receive FDA 510(k) clearance?

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

Who is the listed applicant for ApolloKnee?

The FDA 510(k) record lists Corin U.S.A. Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ApolloKnee?

The FDA product code for ApolloKnee is OLO.

Other records listing Corin U.S.A. Limited 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.

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Related Devices (Code: OLO)

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.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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