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 |