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FDA 510(k)

SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM

K-Number: K012800 · 2002-05-03

ApplicantWhiteside Biomechanics, Inc.
Decision Date2002-05-03
Product CodeHRY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Whiteside Biomechanics, Inc.. It received FDA 510(k) clearance on 2002-05-03 under 510(k) number K012800. The device is classified under product code HRY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM?

SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2002-05-03. The listed applicant is Whiteside Biomechanics, Inc.. The 510(k) number is K012800.

When did SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM receive FDA 510(k) clearance?

SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM received FDA 510(k) clearance on 2002-05-03, under 510(k) number K012800.

Who is the listed applicant for SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM?

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

What is the FDA product code for SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM?

The FDA product code for SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM is HRY.

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Other records listing Whiteside Biomechanics, Inc. 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.

K033313QUATRO M FEMORAL COMPONENTK003618WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014K993903WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013K991678WHITESIDE BIOMECHANICS SPINAL SYSTEMK981238BIPOLAR FEMORAL HEADK973261WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD

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Related Devices (Code: HRY)

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.

K193549SIGMA High Performance (HP) Partial Knee SystemDepuy Ireland UCK190633NanoOrtho NanoKnee® SystemNanoortho, LLCK152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.K131167UNIVATIONAesculap Implant Systems, LLCK122277OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEMBiomet Manufacturing CorpK110415SIGNATURE PLANNER / SIGNATURE GUIDESMaterialise NV

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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