OGmend Implant System

Screw Sleeve Bone Fixation Device

Woven Orthopedic Technologies, LLC

The following data is part of a De Novo classification by Woven Orthopedic Technologies, Llc with the FDA for Ogmend Implant System.

Pre-market Notification Details

DeNovo IDDEN180065
Device Name:OGmend Implant System
ClassificationScrew Sleeve Bone Fixation Device
Applicant Woven Orthopedic Technologies, LLC 63 E. Center Street Manchester,  CT  06040
ContactBob Luzzi
Product CodeQAC  
CFR Regulation Number888.3043 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardOrthopedic
Classification AdvisoryOrthopedic
TypeDirect
Date Received2018-12-13
Decision Date2020-05-01
Reclassification Order:Reclassification Order

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.