Djo Global

FDA Filings

This page includes the latest FDA filings for Djo Global. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Djo Global holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• TOP MEDICAL CORP.
• David Lennarz
• Dave Hunter
• DJO Global / Germany
• DJO Tunisie
• DJO FRANCE SAS
• CHINA STAR PRODUCTS (DONGGUAN) LTD.
• WENZHOU JIANDA MEDICAL INSTRUMENT CO., LTD.
• DJO CANADA INC.
• REX WORKMAN
• NGOC HA SHOES JOINT STOCK COMPANY

FDA Filings

Device Company	Device	Date
PMA P050050S020 DJO Global	Scandinavian Total Ankle Replacement (S.T.A.R. Ankle)	2021-12-17
PMA P050050S019 DJO Global	Scandinavian Total Ankle Replacement (S.T.A.R. Ankle)	2021-08-23
PMN K141006 DJO GLOBAL	RSP HUMERAL SOCKET INSERT	2014-06-05

Similar & Related FDA Registered Companies

• DJO Global Inc
• 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• 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 - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092432129	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	OPTIFLEX K 1 HS CODE 90191090	10 PKG
2020092451328	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	VITALSTIM PLUS ELECTROTHERAPHY SYSTEMS, PRIMERA TENS NMES KIT	21 PKG
20200909124055	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	OPTIFLEX K 1 HS CODE 90191090	10 PKG
2020081541318	Bremerhaven,Federal Republic of Germany -> Houston, Texas	MEDICAL, SURGICAL, DENTAL OR VETERINARY FURNITURE, NESOI	13 PKG
2020081541319	Bremerhaven,Federal Republic of Germany -> Houston, Texas	MEDICAL, SURGICAL, DENTAL OR VETERINARY FURNITURE, NESOI	11 PKG
2020081422010	Gdynia,Poland -> Houston, Texas	MEDICAL, SURGICAL, DENTAL OR VETERINARY FURNITURE, NESOI	12 PKG
2020081327590	Gdynia,Poland -> Houston, Texas	MEDICAL, SURGICAL, DENTAL OR VETERINARY FURNITURE, NESOI	12 PKG
2020081231006	Gdynia,Poland -> Houston, Texas	MEDICAL, SURGICAL, DENTAL OR VETERINARY FURNITURE, NESOI	12 PKG