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FDA 510(k)

Zimmer Biomet Select Ceramic Heads

K-Number: K181761 · 2018-12-26

ApplicantZimmer, Inc.
Decision Date2018-12-26
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer Biomet Select Ceramic Heads is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 2018-12-26 under 510(k) number K181761. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zimmer Biomet Select Ceramic Heads?

Zimmer Biomet Select Ceramic Heads is a medical device that received FDA 510(k) clearance on 2018-12-26. The listed applicant is Zimmer, Inc.. The 510(k) number is K181761.

When did Zimmer Biomet Select Ceramic Heads receive FDA 510(k) clearance?

Zimmer Biomet Select Ceramic Heads received FDA 510(k) clearance on 2018-12-26, under 510(k) number K181761.

Who is the listed applicant for Zimmer Biomet Select Ceramic Heads?

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 Select Ceramic Heads?

The FDA product code for Zimmer Biomet Select Ceramic Heads is LZO.

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_INVITATIONNCT04984291Zimmer Biomet Shoulder Arthroplasty PMCFRECRUITINGNCT05391828Persona MC vs PS RCT With ROSARECRUITINGNCT06089291Persona IQ Cohort StudyACTIVE_NOT_RECRUITINGNCT06388993Marrow Cellution™ vs. Traditional BMA Harvest ProjectRECRUITINGNCT06920459Zimmer Biomet Shoulder Arthroplasty PMCF StudyRECRUITING

Other records listing Zimmer, Inc. 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.

PMA P060037Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearingK261683Augment Off-Axis Instrument SystemK260831Z1 Hip SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer 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: LZO)

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.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, 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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