The following data is part of a premarket notification filed by Intellijoint Surgical Inc. with the FDA for Intellijoint Hip(tm) System.
| Device ID | K151364 |
| 510k Number | K151364 |
| Device Name: | Intellijoint HIP(tm) System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | INTELLIJOINT SURGICAL INC. 60 BATHURST DR., UNIT 1 Waterloo, CA N2v 2a9 |
| Contact | Brandon Gingrich |
| Correspondent | Brandon Gingrich INTELLIJOINT SURGICAL INC. 60 BATHURST DR., UNIT 1 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 | 2015-05-21 |
| Decision Date | 2015-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628184002704 | K151364 | 000 |
| 00628184002070 | K151364 | 000 |
| 00628184002063 | K151364 | 000 |
| 00628184002025 | K151364 | 000 |
| 00628184001974 | K151364 | 000 |
| 00628184001905 | K151364 | 000 |
| 00628184001899 | K151364 | 000 |
| 00628184001721 | K151364 | 000 |
| 00628184001639 | K151364 | 000 |
| 00628184001615 | K151364 | 000 |
| 00628184001608 | K151364 | 000 |
| 00628184001592 | K151364 | 000 |
| 00628184001585 | K151364 | 000 |
| 00628184002087 | K151364 | 000 |
| 00628184002094 | K151364 | 000 |
| 00628184002605 | K151364 | 000 |
| 00628184002520 | K151364 | 000 |
| 00628184002513 | K151364 | 000 |
| 00628184002506 | K151364 | 000 |
| 00628184002490 | K151364 | 000 |
| 00628184002476 | K151364 | 000 |
| 00628184002414 | K151364 | 000 |
| 00628184002346 | K151364 | 000 |
| 00628184002339 | K151364 | 000 |
| 00628184002292 | K151364 | 000 |
| 00628184002148 | K151364 | 000 |
| 00628184002117 | K151364 | 000 |
| 00628184001523 | K151364 | 000 |