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FDA 510(k)

WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014

K-Number: K003618 · 2001-05-23

ApplicantWhiteside Biomechanics, Inc.
Decision Date2001-05-23
Product CodeNDD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 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 2001-05-23 under 510(k) number K003618. The device is classified under product code NDD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014?

WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 is a medical device that received FDA 510(k) clearance on 2001-05-23. The listed applicant is Whiteside Biomechanics, Inc.. The 510(k) number is K003618.

When did WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 receive FDA 510(k) clearance?

WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 received FDA 510(k) clearance on 2001-05-23, under 510(k) number K003618.

Who is the listed applicant for WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014?

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 LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014?

The FDA product code for WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 is NDD.

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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 SYSTEMK993903WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013K991678WHITESIDE BIOMECHANICS SPINAL SYSTEMK981238BIPOLAR FEMORAL HEADK973261WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD

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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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