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FDA 510(k)

PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT

K-Number: K970346 · 1997-02-19

ApplicantKairos Orthopaedics
Decision Date1997-02-19
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Kairos Orthopaedics. It received FDA 510(k) clearance on 1997-02-19 under 510(k) number K970346. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT?

PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1997-02-19. The listed applicant is Kairos Orthopaedics. The 510(k) number is K970346.

When did PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT receive FDA 510(k) clearance?

PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT received FDA 510(k) clearance on 1997-02-19, under 510(k) number K970346.

Who is the listed applicant for PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT?

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

What is the FDA product code for PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT?

The FDA product code for PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT is LZO.

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Related Devices (Code: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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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