The following data is part of a premarket notification filed by Intellijoint Surgical Inc. with the FDA for Intellijoint Hip System (cart), Intellijoint Hip System (portable), Intellijoint Hip Instrument Tray.
| Device ID | K172849 |
| 510k Number | K172849 |
| Device Name: | Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-20 |
| Decision Date | 2017-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628184003732 | K172849 | 000 |
| 00628184003763 | K172849 | 000 |
| 00628184003770 | K172849 | 000 |
| 00628184002827 | K172849 | 000 |
| 00628184002834 | K172849 | 000 |
| 00628184002841 | K172849 | 000 |
| 00628184002858 | K172849 | 000 |
| 00628184003664 | K172849 | 000 |
| 00628184003688 | K172849 | 000 |
| 00628184003862 | K172849 | 000 |