The following data is part of a premarket notification filed by Intellijoint Surgical Inc. with the FDA for Intellijoint® Navigation System.
Device ID | K191507 |
510k Number | K191507 |
Device Name: | Intellijoint® Navigation System |
Classification | Orthopedic Stereotaxic Instrument |
Applicant | Intellijoint Surgical Inc. 60 Bathurst Drive Unit 6 Waterloo, CA N2v 2a9 |
Contact | Breanne Cuddington |
Correspondent | Breanne Cuddington Intellijoint Surgical Inc. 809 Wellington St. N, Unit 2 Kitchener, CA N2h 5l6 |
Product Code | OLO |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-06-06 |
Decision Date | 2019-10-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00628184005514 | K191507 | 000 |
00628184004012 | K191507 | 000 |
00628184002810 | K191507 | 000 |
00628184005613 | K191507 | 000 |
00628184005606 | K191507 | 000 |
00628184005590 | K191507 | 000 |
00628184005668 | K191507 | 000 |
00628184008157 | K191507 | 000 |
00628184008140 | K191507 | 000 |
00628184008133 | K191507 | 000 |
00628184008126 | K191507 | 000 |
00628184008119 | K191507 | 000 |
00628184008034 | K191507 | 000 |
00628184008027 | K191507 | 000 |
00628184008010 | K191507 | 000 |
00628184003930 | K191507 | 000 |
00628184519004 | K191507 | 000 |
00628184005460 | K191507 | 000 |
00628184005415 | K191507 | 000 |
00628184005361 | K191507 | 000 |
00628184005309 | K191507 | 000 |
00628184005262 | K191507 | 000 |
00628184005217 | K191507 | 000 |
00628184005194 | K191507 | 000 |
00628184005132 | K191507 | 000 |
00628184005088 | K191507 | 000 |
00628184005026 | K191507 | 000 |
00628184005019 | K191507 | 000 |
00628184005507 | K191507 | 000 |
00628184005187 | K191507 | 000 |
00628184003879 | K191507 | 000 |
00628184008003 | K191507 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INTELLIJOINT 98026941 not registered Live/Pending |
The Equity Engineering Group, Inc 2023-06-04 |
INTELLIJOINT 86138663 4920357 Live/Registered |
INTELLIJOINT SURGICAL INC. 2013-12-09 |
INTELLIJOINT 86087956 4736066 Live/Registered |
Intellijoint Surgical Inc. 2013-10-10 |
INTELLIJOINT 85516870 4197993 Dead/Cancelled |
The Jones Group APC 2012-01-15 |