KeriFlex® MCP And PIP Finger Joint Prostheses

Prosthesis, Finger, Constrained, Polymer

Keri Medical SA

The following data is part of a premarket notification filed by Keri Medical Sa with the FDA for Keriflex® Mcp And Pip Finger Joint Prostheses.

Pre-market Notification Details

Device IDK211385
510k NumberK211385
Device Name:KeriFlex® MCP And PIP Finger Joint Prostheses
ClassificationProsthesis, Finger, Constrained, Polymer
Applicant Keri Medical SA Route Des Acacias, 45a Geneva,  CH CH-1227
ContactBernard Prandi
CorrespondentBernard Prandi
Keri Medical SA Route Des Acacias, 45a Geneva,  CH CH-1227
Product CodeKYJ  
CFR Regulation Number888.3230 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-04
Decision Date2022-07-27

Trademark Results [KeriFlex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KERIFLEX
KERIFLEX
97532902 not registered Live/Pending
KERI MEDICAL SA
2022-08-03
KERIFLEX
KERIFLEX
88361038 not registered Live/Pending
Wellin Inc.
2019-03-28

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.