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 |