The following data is part of a premarket notification filed by Orthogrid Systems Inc. with the FDA for Phantommsk Trauma.
| Device ID | K192279 |
| 510k Number | K192279 |
| Device Name: | PhantomMSK Trauma |
| Classification | System, Image Processing, Radiological |
| Applicant | OrthoGrid Systems Inc. 3216 South Highland, Suite 202 Salt Lake City, UT 84106 |
| Contact | Sebastian Edin |
| Correspondent | Sebastian Edin OrthoGrid Systems Inc. 3216 South Highland, Suite 202 Salt Lake City, UT 84106 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-22 |
| Decision Date | 2019-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003424827 | K192279 | 000 |
| 00860003424841 | K192279 | 000 |