The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Oryx Cervical Plate System.
| Device ID | K192049 |
| 510k Number | K192049 |
| Device Name: | Oryx Cervical Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107 |
| Contact | Marshall Mccarty |
| Correspondent | Marshall Mccarty Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-31 |
| Decision Date | 2019-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M711AP1080 | K192049 | 000 |
| M711AP2420 | K192049 | 000 |
| M711AP2440 | K192049 | 000 |
| M711AP2460 | K192049 | 000 |
| M711AP3420 | K192049 | 000 |
| M711AP3450 | K192049 | 000 |
| M711AP3480 | K192049 | 000 |
| M711AP3510 | K192049 | 000 |
| M711AP3540 | K192049 | 000 |
| M711AP3570 | K192049 | 000 |
| M711AP3600 | K192049 | 000 |
| M711AP3630 | K192049 | 000 |
| M711AP3660 | K192049 | 000 |
| M711AP4520 | K192049 | 000 |
| M711AP4550 | K192049 | 000 |
| M711AP4580 | K192049 | 000 |
| M711AP2400 | K192049 | 000 |
| M711AP2380 | K192049 | 000 |
| M711AP2360 | K192049 | 000 |
| M711AP1100 | K192049 | 000 |
| M711AP1120 | K192049 | 000 |
| M711AP1140 | K192049 | 000 |
| M711AP1160 | K192049 | 000 |
| M711AP1180 | K192049 | 000 |
| M711AP1200 | K192049 | 000 |
| M711AP1220 | K192049 | 000 |
| M711AP1240 | K192049 | 000 |
| M711AP1260 | K192049 | 000 |
| M711AP2240 | K192049 | 000 |
| M711AP2260 | K192049 | 000 |
| M711AP2280 | K192049 | 000 |
| M711AP2300 | K192049 | 000 |
| M711AP2320 | K192049 | 000 |
| M711AP2340 | K192049 | 000 |
| M711AP4610 | K192049 | 000 |
| M711AP4640 | K192049 | 000 |
| M711AP4670 | K192049 | 000 |
| M711APF45180 | K192049 | 000 |
| M711APF45200 | K192049 | 000 |
| M711APV40120 | K192049 | 000 |
| M711APV40130 | K192049 | 000 |
| M711APV40140 | K192049 | 000 |
| M711APV40150 | K192049 | 000 |
| M711APV40160 | K192049 | 000 |
| M711APV40170 | K192049 | 000 |
| M711APV40180 | K192049 | 000 |
| M711APV40190 | K192049 | 000 |
| M711APV40200 | K192049 | 000 |
| M711APV45120 | K192049 | 000 |
| M711APV45140 | K192049 | 000 |
| M711APV45160 | K192049 | 000 |
| M711APV45180 | K192049 | 000 |
| M711APF45160 | K192049 | 000 |
| M711APF45140 | K192049 | 000 |
| M711APF45120 | K192049 | 000 |
| M711AP4700 | K192049 | 000 |
| M711AP4730 | K192049 | 000 |
| M711AP4760 | K192049 | 000 |
| M711AP4790 | K192049 | 000 |
| M711AP4820 | K192049 | 000 |
| M711AP4850 | K192049 | 000 |
| M711APF40120 | K192049 | 000 |
| M711APF40130 | K192049 | 000 |
| M711APF40140 | K192049 | 000 |
| M711APF40150 | K192049 | 000 |
| M711APF40160 | K192049 | 000 |
| M711APF40170 | K192049 | 000 |
| M711APF40180 | K192049 | 000 |
| M711APF40190 | K192049 | 000 |
| M711APF40200 | K192049 | 000 |
| M711APV45200 | K192049 | 000 |