The following data is part of a premarket notification filed by Intellijoint Surgical Inc. with the FDA for Intellijoint View.
Device ID | K211876 |
510k Number | K211876 |
Device Name: | Intellijoint VIEW |
Classification | System, Image Processing, Radiological |
Applicant | Intellijoint Surgical Inc. 809 Wellington Street North , Unit 2 Kitchener, CA N2h 5l6 |
Contact | Katarina Jugovic |
Correspondent | Katarina Jugovic Intellijoint Surgical Inc. 809 Wellington Street North , Unit 2 Kitchener, CA N2h 5l6 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-06-17 |
Decision Date | 2021-11-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INTELLIJOINT VIEW 90874283 not registered Live/Pending |
Intellijoint Surgical, Inc. 2021-08-10 |