FDA 510(k)

BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT

K-Number: K921557 · 1994-02-22

Decision Date1994-02-22

Product CodeLPH

Advisory CommitteeOR

DecisionUnknown

Device Summary

BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K921557. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT?

BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Zimmer, Inc.. The 510(k) number is K921557.

When did BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT receive FDA 510(k) clearance?

BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT received FDA 510(k) clearance on 1994-02-22, under 510(k) number K921557.

Who is the listed applicant for BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT?

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 ACETABULAR COMPONENT?

The FDA product code for BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT is LPH.

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Other records listing Zimmer, Inc. as applicant

K262955OsseoFit Stemless Shoulder System K260831Z1 Hip System K261683Augment Off-Axis Instrument System K251840Zimmer® Persona® Personalized Knee System K260182Avenir® Müller Stem; Avenir Complete™ Hip System K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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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.