The following data is part of a premarket notification filed by Intellijoint Surgical Inc. with the FDA for Intellijoint Hip Generation 2b System.
| Device ID | K171525 |
| 510k Number | K171525 |
| Device Name: | Intellijoint HIP Generation 2B System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Intellijoint Surgical Inc. 60 Bathurst Drive Unit 6 Waterloo, CA N2v 2a9 |
| Contact | Brandon Gingrich |
| Correspondent | Brandon Gingrich Intellijoint Surgical Inc. 60 Bathurst Drive 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 | 2017-05-25 |
| Decision Date | 2017-10-30 |
| Summary: | summary |