The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Opteryx Anterior Cervical Plate System.
| Device ID | K061147 |
| 510k Number | K061147 |
| Device Name: | OPTERYX ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | INNOVASIS, INC. 614 EAST 3900 SOUTH Salt Lake City, UT 84107 |
| Contact | David N Mckean |
| Correspondent | David N Mckean 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 | 2006-04-25 |
| Decision Date | 2006-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M711CI0100 | K061147 | 000 |
| M711CP20200 | K061147 | 000 |
| M711CP21120 | K061147 | 000 |
| M711CP21130 | K061147 | 000 |
| M711CP21140 | K061147 | 000 |
| M711CP21150 | K061147 | 000 |
| M711CP21160 | K061147 | 000 |
| M711CP21170 | K061147 | 000 |
| M711CP21180 | K061147 | 000 |
| M711CP21190 | K061147 | 000 |
| M711CP21200 | K061147 | 000 |
| M711CP220 | K061147 | 000 |
| M711CP22120 | K061147 | 000 |
| M711CP22140 | K061147 | 000 |
| M711CP22160 | K061147 | 000 |
| M711CP20190 | K061147 | 000 |
| M711CP20180 | K061147 | 000 |
| M711CI0120 | K061147 | 000 |
| M711CI0300 | K061147 | 000 |
| M711CI0310 | K061147 | 000 |
| M711CP120 | K061147 | 000 |
| M711CP140 | K061147 | 000 |
| M711CP160 | K061147 | 000 |
| M711CP180 | K061147 | 000 |
| M711CP200 | K061147 | 000 |
| M711CP20120 | K061147 | 000 |
| M711CP20130 | K061147 | 000 |
| M711CP20140 | K061147 | 000 |
| M711CP20150 | K061147 | 000 |
| M711CP20160 | K061147 | 000 |
| M711CP20170 | K061147 | 000 |
| M711CP22180 | K061147 | 000 |
| M711CP22200 | K061147 | 000 |
| M711CP23120 | K061147 | 000 |
| M711CP530 | K061147 | 000 |
| M711CP560 | K061147 | 000 |
| M711CP590 | K061147 | 000 |
| M711CP620 | K061147 | 000 |
| M711CP680 | K061147 | 000 |
| M711CP710 | K061147 | 000 |
| M711CP740 | K061147 | 000 |
| M711CP770 | K061147 | 000 |
| M711CP800 | K061147 | 000 |
| M711CI1000 | K061147 | 000 |
| M711CI0900 | K061147 | 000 |
| M711CI0400 | K061147 | 000 |
| M711CI0500 | K061147 | 000 |
| M711CI1100 | K061147 | 000 |
| M711CP500 | K061147 | 000 |
| M711CP470 | K061147 | 000 |
| M711CP23140 | K061147 | 000 |
| M711CP23160 | K061147 | 000 |
| M711CP23180 | K061147 | 000 |
| M711CP23200 | K061147 | 000 |
| M711CP240 | K061147 | 000 |
| M711CP260 | K061147 | 000 |
| M711CP280 | K061147 | 000 |
| M711CP300 | K061147 | 000 |
| M711CP320 | K061147 | 000 |
| M711CP340 | K061147 | 000 |
| M711CP360 | K061147 | 000 |
| M711CP380 | K061147 | 000 |
| M711CP410 | K061147 | 000 |
| M711CP440 | K061147 | 000 |
| M711CI0600 | K061147 | 000 |