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 |