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FDA 510(k)

MICRO-SEAL ACETABULAR SYSTEM

K-Number: K971718 · 1997-07-23

ApplicantWhiteside Biomechanics, Inc.
Decision Date1997-07-23
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MICRO-SEAL ACETABULAR 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 1997-07-23 under 510(k) number K971718. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-SEAL ACETABULAR SYSTEM?

MICRO-SEAL ACETABULAR SYSTEM is a medical device that received FDA 510(k) clearance on 1997-07-23. The listed applicant is Whiteside Biomechanics, Inc.. The 510(k) number is K971718.

When did MICRO-SEAL ACETABULAR SYSTEM receive FDA 510(k) clearance?

MICRO-SEAL ACETABULAR SYSTEM received FDA 510(k) clearance on 1997-07-23, under 510(k) number K971718.

Who is the listed applicant for MICRO-SEAL ACETABULAR 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 MICRO-SEAL ACETABULAR SYSTEM?

The FDA product code for MICRO-SEAL ACETABULAR SYSTEM is LPH.

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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

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Related Devices (Code: LPH)

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.

K261453G7® Acetabular SystemZimmer BiometK253630Mpact 3D Metal FoamMedacta International S.A.K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, 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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