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 |
|---|---|---|
| M711CI0600 | K061147 | 000 |
| M711CI1100 | K061147 | 000 |
| M711CI0500 | K061147 | 000 |
| M711CI0400 | K061147 | 000 |
| M711CI0900 | K061147 | 000 |
| M711CI1000 | K061147 | 000 |