Compressyn™ Staple

Staple, Fixation, Bone

Dallen Medical, Inc.

The following data is part of a premarket notification filed by Dallen Medical, Inc. with the FDA for Compressyn™ Staple.

Pre-market Notification Details

Device IDK171473
510k NumberK171473
Device Name:Compressyn™ Staple
ClassificationStaple, Fixation, Bone
Applicant Dallen Medical, Inc. 1046 Calle Recodo, Suite G San Clemente,  CA  92673
ContactAl Memmolo
CorrespondentAl Memmolo
Dallen Medical, Inc. 1046 Calle Recodo, Suite G San Clemente,  CA  92673
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-19
Decision Date2017-11-07
Summary:summary

Trademark Results [Compressyn]

Mark Image

Registration | Serial
Company
Trademark
Application Date
COMPRESSYN
COMPRESSYN
85922035 4893296 Live/Registered
Dallen Medical, Inc.
2013-05-02
COMPRESSYN
COMPRESSYN
77648818 not registered Dead/Abandoned
Dallen Medical, Inc.
2009-01-13

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.