Speed, Speed Shift, Speed Titan, Speed Arc

Staple, Fixation, Bone

BioMedical Enterprises, Inc.

The following data is part of a premarket notification filed by Biomedical Enterprises, Inc. with the FDA for Speed, Speed Shift, Speed Titan, Speed Arc.

Pre-market Notification Details

Device IDK142292
510k NumberK142292
Device Name:Speed, Speed Shift, Speed Titan, Speed Arc
ClassificationStaple, Fixation, Bone
Applicant BioMedical Enterprises, Inc. 14785 Omicron Dr., Suite 205 San Antonio,  TX  78245
ContactJoe Soward
CorrespondentJoe Soward
BioMedical Enterprises, Inc. 14785 Omicron Dr., Suite 205 San Antonio,  TX  78245
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-18
Decision Date2014-11-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00810633022023 K142292 000
00810633022016 K142292 000
00810633022009 K142292 000
00810633021996 K142292 000

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