FDA.reportPublic FDA data

DJO GLOBAL SWITZERLAND SARL

Matched from indexed company URL: Djo Global

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30036789583003678958DJO GLOBAL SWITZERLAND SARL1N2026-01-01ZI Larges Pieces A Chemin du Devent Ecublens Vaud CH CH-1024
30077405913007740591DJO Global / Germany1N2026-01-01ORMED GmbH Boetzinger Strasse 90 Freiburg Baden-Wurttemberg DE 79111

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1774091705762804K011880COMPEX SPORTNGX2002-04-17
1772491832221313
1772491993613208

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NGX12002-04-17

PMA#

Scandinavian Total Ankle Replacement (STAR Ankle)

2022-09-29

DJO Global9800 Metric Boulevardaustin, TX 78758 PMA NumberP050050 Supplement NumberS025 Date Received09/02/2022 Decision Date09/29/2022 Product Code NTG  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufactu...

Scandinavian Total Ankle Replacement (STAR Ankle)

2022-03-11

DJO Global9800 Metric Boulevardaustin, TX 78758 PMA NumberP050050 Supplement NumberS022 Date Received02/01/2022 Decision Date03/11/2022 Product Code NTG  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufactu...

PMN#