Si-Mochi

Filler, Bone Void, Calcium Compound

Biostone Ltd

The following data is part of a premarket notification filed by Biostone Ltd with the FDA for Si-mochi.

Pre-market Notification Details

Device IDK202639
510k NumberK202639
Device Name:Si-Mochi
ClassificationFiller, Bone Void, Calcium Compound
Applicant Biostone Ltd BioCity, Pennyfoot Street Nottingham,  GB Ng1 1gf
ContactWei-jen Lo
CorrespondentWei-jen Lo
Biostone Ltd BioCity, Pennyfoot Street Nottingham,  GB Ng1 1gf
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-11
Decision Date2021-04-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060548020095 K202639 000
05060548020125 K202639 000
05060548020279 K202639 000
05060548020262 K202639 000
05060548020255 K202639 000
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05060548020231 K202639 000
05060548020224 K202639 000
05060548020217 K202639 000
05060548020347 K202639 000
05060548020330 K202639 000
05060548020132 K202639 000
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05060548020101 K202639 000
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05060548020002 K202639 000
05060548020200 K202639 000
05060548020194 K202639 000
05060548020163 K202639 000
05060548020156 K202639 000
05060548020293 K202639 000

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