The following data is part of a premarket notification filed by Orthogrid Systems, Inc with the FDA for Phantommsk Hip.
| Device ID | K210136 |
| 510k Number | K210136 |
| Device Name: | PhantomMSK Hip |
| Classification | System, Image Processing, Radiological |
| Applicant | OrthoGrid Systems, Inc 3865 Wasatch Boulevard Suite 301 Salt Lake City, UT 84109 |
| Contact | Trevor Hafer |
| Correspondent | Trevor Hafer OrthoGrid Systems, Inc 3865 Wasatch Boulevard Suite 301 Salt Lake City, UT 84109 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-19 |
| Decision Date | 2021-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003424810 | K210136 | 000 |
| 00860003424803 | K210136 | 000 |
| 00860003424834 | K210136 | 000 |