FDA 510(k)

Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head

K-Number: K183457 · 2019-11-05

Decision Date2019-11-05

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2019-11-05 under 510(k) number K183457. 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 Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head?

Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head is a medical device that received FDA 510(k) clearance on 2019-11-05. The listed applicant is Zimmer, Inc.. The 510(k) number is K183457.

When did Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head receive FDA 510(k) clearance?

Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head received FDA 510(k) clearance on 2019-11-05, under 510(k) number K183457.

Who is the listed applicant for Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head?

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 Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head?

The FDA product code for Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head is LPH.

Related Clinical Trials

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.

NCT03506334Anterior Vertebral Body Tethering (AVBT) Using Zimmer Biomet Tether System or Dynesys System Components to Treat Pediatric ScoliosisENROLLING_BY_INVITATION NCT04984291Zimmer Biomet Shoulder Arthroplasty PMCFRECRUITING NCT05391828Persona MC vs PS RCT With ROSARECRUITING NCT06089291Persona IQ Cohort StudyACTIVE_NOT_RECRUITING NCT06388993Marrow Cellution™ vs. Traditional BMA Harvest ProjectRECRUITING NCT06920459Zimmer Biomet Shoulder Arthroplasty PMCF StudyRECRUITING

Other records listing Zimmer, Inc. as applicant

PMA P060037Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing K261683Augment Off-Axis Instrument System K260831Z1 Hip 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)

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.K252623G7® Revision Acetabular SystemZimmer, Inc.K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.

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.