Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Comprehensive Nano Stemless Shoulder

K-Number: K182516 · 2019-04-22

ApplicantBiomet Manufacturing Corp
Decision Date2019-04-22
Product CodePKC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Comprehensive Nano Stemless Shoulder is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2019-04-22 under 510(k) number K182516. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Comprehensive Nano Stemless Shoulder?

Comprehensive Nano Stemless Shoulder is a medical device that received FDA 510(k) clearance on 2019-04-22. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K182516.

When did Comprehensive Nano Stemless Shoulder receive FDA 510(k) clearance?

Comprehensive Nano Stemless Shoulder received FDA 510(k) clearance on 2019-04-22, under 510(k) number K182516.

Who is the listed applicant for Comprehensive Nano Stemless Shoulder?

The FDA 510(k) record lists Biomet Manufacturing Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Comprehensive Nano Stemless Shoulder?

The FDA product code for Comprehensive Nano Stemless Shoulder is PKC.

Other records listing Biomet Manufacturing 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.

PMA P010014Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearingK230540Patient Specific Planning Solution™ 3D Bone ModelsK214001Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemK211729Comprehensive® Convertible Glenoid - Vivacit-E LinerK202232Comprehensive Vault Reconstruction SystemK193038Comprehensive Shoulder System

View all 16 devices →

Related Devices (Code: PKC)

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.

K254154FX V135 EASYTECH® Shoulder SystemFX Shoulder Solutions, Inc.K252129AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K243248INHANCE INTACT™Depuy Ireland UCK241873OsseoFit Stemless Shoulder SystemZimmer, Inc.K240716AETOS Shoulder System Stemless Humeral ProsthesisSmith & Nephew, Inc.K221758SMR Stemless AnatomicLima Corporate S.P.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.

↑