FDA 510(k)

INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT

K-Number: K983509 · 1999-02-03

Decision Date1999-02-03

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Orthopedics, Inc.. It received FDA 510(k) clearance on 1999-02-03 under 510(k) number K983509. 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 INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT?

INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT is a medical device that received FDA 510(k) clearance on 1999-02-03. The listed applicant is Sulzer Orthopedics, Inc.. The 510(k) number is K983509.

When did INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT receive FDA 510(k) clearance?

INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT received FDA 510(k) clearance on 1999-02-03, under 510(k) number K983509.

Who is the listed applicant for INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT?

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

What is the FDA product code for INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT?

The FDA product code for INTER-OP ACETABULAR SYSTEM - DURASUL ACETABULAR INSERT is LPH.

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Other records listing Sulzer Orthopedics, Inc. as applicant

K022985ASCENDENT ACETABULAR SYSTEM K021578NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE K020713MS-30 LATERAL FEMORAL STEM K013935ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS K013031MOST OPTIONS SYSTEM K012739CONVERGE ACETABULAR SYSTEM

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Related Devices (Code: LPH)

K261453G7® Acetabular SystemZimmer Biomet K253630Mpact 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 Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, Inc.

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.