KOSMO Femoral Stem

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

B-One Ortho Corp.

The following data is part of a premarket notification filed by B-one Ortho Corp. with the FDA for Kosmo Femoral Stem.

Pre-market Notification Details

Device IDK202768
510k NumberK202768
Device Name:KOSMO Femoral Stem
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant b-One Ortho Corp. 3 Wing Drive Suite #259 Cedar Knolls,  NJ  07927
ContactAllison Gecik
CorrespondentAllison Gecik
b-One Ortho Corp. 3 Wing Drive Suite #259 Cedar Knolls,  NJ  07927
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-21
Decision Date2021-04-01

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