FDA 510(k)

OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM

K-Number: K983502 · 1998-12-16

Decision Date1998-12-16

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1998-12-16 under 510(k) number K983502. 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 OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM?

OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM is a medical device that received FDA 510(k) clearance on 1998-12-16. The listed applicant is Osteonics Corp.. The 510(k) number is K983502.

When did OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM receive FDA 510(k) clearance?

OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM received FDA 510(k) clearance on 1998-12-16, under 510(k) number K983502.

Who is the listed applicant for OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM?

The FDA 510(k) record lists Osteonics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM?

The FDA product code for OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM is LPH.

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Other records listing Osteonics Corp. as applicant

K983657OSTEONICS SERIES 7000 AD TIBIAL TRAY K980070OSTEONICS HA-COATED DEVICES K984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY K982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM K984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE K990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

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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.