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FDA 510(k)

METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD

K-Number: K082146 · 2008-09-09

ApplicantAesculap Implant Systems, Inc.
Decision Date2008-09-09
Product CodeLWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD 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 2008-09-09 under 510(k) number K082146. The device is classified under product code LWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD?

METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 2008-09-09. The listed applicant is Aesculap Implant Systems, Inc.. The 510(k) number is K082146.

When did METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD receive FDA 510(k) clearance?

METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD received FDA 510(k) clearance on 2008-09-09, under 510(k) number K082146.

Who is the listed applicant for METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD?

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 METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD?

The FDA product code for METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD is LWJ.

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Other records listing Aesculap Implant Systems, Inc. as applicant

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Related Devices (Code: LWJ)

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.

K120595UNISYN PLUS HIP STEMConsensus Orthopedics, Inc.K103518TRINITY ACETABULAR SYSTEMCorin USAK090764NOVATION CFS PRESS-FIT AND CEMENTED STEMSExactech, Inc.K07006136MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERTHayes Medical, Inc.K062978U2 HIP STEM, TI PLASMA SPRAYUnited Orthopedic Corp.K062383UNISYN HA PLASMA MODULAR HIPHayes Medical, Inc.

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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