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FDA 510(k)

BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS

K-Number: K090299 · 2009-04-24

ApplicantAesculap Implant Systems
Decision Date2009-04-24
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems. It received FDA 510(k) clearance on 2009-04-24 under 510(k) number K090299. 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 BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS?

BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS is a medical device that received FDA 510(k) clearance on 2009-04-24. The listed applicant is Aesculap Implant Systems. The 510(k) number is K090299.

When did BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS receive FDA 510(k) clearance?

BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS received FDA 510(k) clearance on 2009-04-24, under 510(k) number K090299.

Who is the listed applicant for BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS?

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

What is the FDA product code for BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS?

The FDA product code for BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS is LZO.

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Other records listing Aesculap Implant Systems 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.

K121879VEGA KNEE SYSTEMK101815ENDURO KNEE SYSTEMK100623AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEMK090657MODIFICATION TO: S4 SPINAL SYSTEMK071945S4 SPINAL SYSTEM

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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