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FDA 510(k)

WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD

K-Number: K971721 · 1997-07-30

ApplicantWhiteside Biomechanics, Inc.
Decision Date1997-07-30
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD 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 1997-07-30 under 510(k) number K971721. 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 WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD?

WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 1997-07-30. The listed applicant is Whiteside Biomechanics, Inc.. The 510(k) number is K971721.

When did WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD receive FDA 510(k) clearance?

WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD received FDA 510(k) clearance on 1997-07-30, under 510(k) number K971721.

Who is the listed applicant for WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD?

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 WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD?

The FDA product code for WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD is LZO.

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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.

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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 COMPONENTK012800SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEMK003618WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014K993903WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013K991678WHITESIDE BIOMECHANICS SPINAL SYSTEMK981238BIPOLAR FEMORAL HEAD

View all 13 devices →

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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