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FDA 510(k)

MODIFICATION TO: METHA HIP SYSTEM

K-Number: K083495 · 2009-01-15

ApplicantAesculap Implant Systems, Inc.
Decision Date2009-01-15
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: METHA HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems, Inc.. It received FDA 510(k) clearance on 2009-01-15 under 510(k) number K083495. 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 MODIFICATION TO: METHA HIP SYSTEM?

MODIFICATION TO: METHA HIP SYSTEM is a medical device that received FDA 510(k) clearance on 2009-01-15. The listed applicant is Aesculap Implant Systems, Inc.. The 510(k) number is K083495.

When did MODIFICATION TO: METHA HIP SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO: METHA HIP SYSTEM received FDA 510(k) clearance on 2009-01-15, under 510(k) number K083495.

Who is the listed applicant for MODIFICATION TO: METHA HIP SYSTEM?

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

What is the FDA product code for MODIFICATION TO: METHA HIP SYSTEM?

The FDA product code for MODIFICATION TO: METHA HIP SYSTEM is LZO.

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Other records listing Aesculap Implant Systems, Inc. as applicant

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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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