FDA 510(k)

OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)

K-Number: K963946 · 1997-01-27

Decision Date1997-01-27

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION) is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1997-01-27 under 510(k) number K963946. 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 MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)?

OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION) is a medical device that received FDA 510(k) clearance on 1997-01-27. The listed applicant is Osteonics Corp.. The 510(k) number is K963946.

When did OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION) receive FDA 510(k) clearance?

OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION) received FDA 510(k) clearance on 1997-01-27, under 510(k) number K963946.

Who is the listed applicant for OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)?

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 MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)?

The FDA product code for OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION) 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.