Biocore9 Humeral Resurfacing System

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Biocore9, LLC.

The following data is part of a premarket notification filed by Biocore9, Llc. with the FDA for Biocore9 Humeral Resurfacing System.

Pre-market Notification Details

Device IDK193122
510k NumberK193122
Device Name:Biocore9 Humeral Resurfacing System
ClassificationProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant Biocore9, LLC. 9 Whippany Road, Bldg A1, Unit 12 Whippany,  NJ  07981
ContactStan Matlak
CorrespondentStephen J. Peoples
Biocore9, LLC. 9 Whippany Road, Bldg A1, Unit 12 Whippany,  NJ  07981
Product CodeHSD  
CFR Regulation Number888.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-12
Decision Date2020-05-15

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