IlluminOss Bone Stabilization System

Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated

IllminOss Medical, Inc.

The following data is part of a De Novo classification by Illminoss Medical, Inc. with the FDA for Illuminoss Bone Stabilization System.

Pre-market Notification Details

• DeNovo ID: DEN160062
• Device Name: IlluminOss Bone Stabilization System
• Classification: Rod, Fixation, Intramedullary And Accessories, In-vivo Cured, Light-activated
• Applicant: IllminOss Medical, Inc. 993 Waterman Avenue East Providence, RI 02914
• Contact: Fred Tobia
• Product Code: QAD
• CFR Regulation Number: 888.3023 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: Device 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 Board: Orthopedic
• Classification Advisory: Orthopedic
• Type: Direct
• Date Received: 2016-12-28
• Decision Date: 2017-12-19
• FDA Review: Decision Summary
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M986CT03180	DEN160062	000
M986CT01970	DEN160062	000
M986CT03010	DEN160062	000
M986SY2000010	DEN160062	000
M986USML08080	DEN160062	000
M986USML081000	DEN160062	000
M986USML08120	DEN160062	000
M986USML13100700	DEN160062	000
M986USML13100900	DEN160062	000
M986USSL07001600	DEN160062	000
M986USSL07002000	DEN160062	000
M986USSL09001600	DEN160062	000
M986USSL09001800	DEN160062	000
M986USSL09002200	DEN160062	000
M986USSL11001600	DEN160062	000
M986USSL11001800	DEN160062	000
M986CT01960	DEN160062	000
M986CT01950	DEN160062	000
M986CT01880	DEN160062	000
M986USSL2200120	DEN160062	000
M986USSL22132600	DEN160062	000
M986CT03070	DEN160062	000
M986CT03080	DEN160062	000
M986CT03090	DEN160062	000
M986CT03100	DEN160062	000
M986CT03110	DEN160062	000
M986CT03120	DEN160062	000
M986CT03130	DEN160062	000
M986CT03140	DEN160062	000
M986CT03150	DEN160062	000
M986CT03160	DEN160062	000
M986CT03170	DEN160062	000
M986USSL2200100	DEN160062	000
M986CT01860	DEN160062	000
M986USSL11002200	DEN160062	000
M986USSL15001800	DEN160062	000
USSL0900180	DEN160062	000
USSL0900220	DEN160062	000
USSL1100160	DEN160062	000
USSL1100180	DEN160062	000
USSL1100220	DEN160062	000
USSL1500180	DEN160062	000
USSL1500220	DEN160062	000
USSL1500260	DEN160062	000
USSL1500280	DEN160062	000
USSL1700180	DEN160062	000
USSL1700220	DEN160062	000
USSL1700260	DEN160062	000
USSL1700280	DEN160062	000
USSL2213160	DEN160062	000
USSL2213220	DEN160062	000
USSL0900160	DEN160062	000
USSL0700200	DEN160062	000
USSL0700160	DEN160062	000
M986USSL15002200	DEN160062	000
M986USSL15002600	DEN160062	000
M986USSL15002800	DEN160062	000
M986USSL17001800	DEN160062	000
M986USSL17002200	DEN160062	000
M986USSL17002600	DEN160062	000
M986USSL17002800	DEN160062	000
M986USSL22131600	DEN160062	000
M986USSL22132200	DEN160062	000
M986USSL22132400	DEN160062	000
USML08080	DEN160062	000
USML08100	DEN160062	000
USML08120	DEN160062	000
USML1310070	DEN160062	000
USML1310090	DEN160062	000
USSL2213240	DEN160062	000