FDA.reportPublic FDA data

ORTHONOVIS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30159467843015946784ORTHONOVIS, INC.1N2026-01-011 Hargrove Grade Ste 4 Palm Coast FL US 32137

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2345281817943385K252758Cannulated Screw and Kirschner (K wire) SystemHWC2025-10-02
2345281542716301K250498BPS Wrist Fracture SystemHRS2025-03-17
2345281216081768K250055BPS - Bone Fragment Fixation Plates, Screws and WashersHRS2025-02-06
2345282021434309K242343BPS Wrist Fracture SystemHRS2024-10-04
2345281473780958K213905ONX Large External Fixation SystemKTT2022-08-25
2345282016275289K203811GPC Intraheal Intramedullary Nailing SystemHSB2022-02-10
2345281797854668K191641AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius ScrewsHRS2019-09-16
2345281236424151K162674BioPro Foot Plating SystemsHRS2017-06-16
2345281801712846K153211M-Fix Acromioclavicular DeviceHTN2016-02-02
2345281255849500K130614BONE FRAGMENT AND FIXATION PLATES, SCREWS AND WASHERSHRS2014-01-17
2345281498401573K130613CANNULATED SCREW AND KIRSCHNER (KWIRE) SYSTEMHWC2014-01-22
2345281681451574K082672NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFTMQV2008-12-09
2345281507198698K061798BIOPRO MEMORY STAPLEJDR2006-08-21
2345281193312215K012990COLLATEK POWDERKGN2001-10-24
2345281864839993

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS62025-03-17
HWC22025-10-02
KTT12022-08-25
HSB12022-02-10
HTN12016-02-02
MQV12008-12-09
JDR12006-08-21
KGN12001-10-24

PMN#