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FDA 510(k)

iNSitu Total Hip System

K-Number: K191936 · 2019-08-20

ApplicantThecken Companies, LLC
Decision Date2019-08-20
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

iNSitu Total Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Thecken Companies, LLC. It received FDA 510(k) clearance on 2019-08-20 under 510(k) number K191936. 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 iNSitu Total Hip System?

iNSitu Total Hip System is a medical device that received FDA 510(k) clearance on 2019-08-20. The listed applicant is Thecken Companies, LLC. The 510(k) number is K191936.

When did iNSitu Total Hip System receive FDA 510(k) clearance?

iNSitu Total Hip System received FDA 510(k) clearance on 2019-08-20, under 510(k) number K191936.

Who is the listed applicant for iNSitu Total Hip System?

The FDA 510(k) record lists Thecken Companies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iNSitu Total Hip System?

The FDA product code for iNSitu Total Hip System is LPH.

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.

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.K252623G7® Revision Acetabular SystemZimmer, Inc.K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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