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FDA 510(k)

OSTEONICS OMNIFIT AD HIP STEM SERIES

K-Number: K940715 · 1995-06-07

ApplicantOsteonics Corp.
Decision Date1995-06-07
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEONICS OMNIFIT AD HIP STEM SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1995-06-07 under 510(k) number K940715. 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 OMNIFIT AD HIP STEM SERIES?

OSTEONICS OMNIFIT AD HIP STEM SERIES is a medical device that received FDA 510(k) clearance on 1995-06-07. The listed applicant is Osteonics Corp.. The 510(k) number is K940715.

When did OSTEONICS OMNIFIT AD HIP STEM SERIES receive FDA 510(k) clearance?

OSTEONICS OMNIFIT AD HIP STEM SERIES received FDA 510(k) clearance on 1995-06-07, under 510(k) number K940715.

Who is the listed applicant for OSTEONICS OMNIFIT AD HIP STEM SERIES?

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 OMNIFIT AD HIP STEM SERIES?

The FDA product code for OSTEONICS OMNIFIT AD HIP STEM SERIES is LPH.

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Other records listing Osteonics Corp. 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.

K983657OSTEONICS SERIES 7000 AD TIBIAL TRAYK980070OSTEONICS HA-COATED DEVICESK984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYK982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEMK984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVEK990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

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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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