101 NEER TYPE SHOULDER

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for 101 Neer Type Shoulder.

Pre-market Notification Details

Device IDK822771
510k NumberK822771
Device Name:101 NEER TYPE SHOULDER
ClassificationProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant INTERMEDICS ORTHOPEDICS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHSD  
CFR Regulation Number888.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-09-14
Decision Date1982-10-06

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