The following data is part of a premarket notification filed by Intellijoint Surgical Inc. with the FDA for Intellijoint Hip Generation 2a System.
| Device ID | K162364 |
| 510k Number | K162364 |
| Device Name: | Intellijoint HIP Generation 2A System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | INTELLIJOINT SURGICAL INC. 60 BATHURST DR., UNIT 6 Waterloo, CA N2v 2a9 |
| Contact | Brandon Gingrich |
| Correspondent | Brandon Gingrich INTELLIJOINT SURGICAL INC. 60 BATHURST DR., UNIT 6 Waterloo, CA N2v 2a9 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-23 |
| Decision Date | 2017-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628184003589 | K162364 | 000 |
| 00628184003565 | K162364 | 000 |
| 00628184003008 | K162364 | 000 |
| 00628184002803 | K162364 | 000 |
| 00628184002759 | K162364 | 000 |