FDA 510(k)

BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM

K-Number: K921639 · 1992-07-02

Decision Date1992-07-02

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1992-07-02 under 510(k) number K921639. 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 BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM?

BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM is a medical device that received FDA 510(k) clearance on 1992-07-02. The listed applicant is Zimmer, Inc.. The 510(k) number is K921639.

When did BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM receive FDA 510(k) clearance?

BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM received FDA 510(k) clearance on 1992-07-02, under 510(k) number K921639.

Who is the listed applicant for BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM?

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

What is the FDA product code for BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM?

The FDA product code for BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM is LPH.

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Other records listing Zimmer, Inc. as applicant

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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

View on FDA Database →

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