The following data is part of a premarket notification filed by Genesys Spine with the FDA for Genesys Spine Anterior Cervical Plate Ii System.
| Device ID | K133245 |
| 510k Number | K133245 |
| Device Name: | GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SOUTH BUILDING THREE, SUITE 600 Austin, TX 78746 |
| Contact | William W Sowers |
| Correspondent | William W Sowers GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SOUTH BUILDING THREE, SUITE 600 Austin, TX 78746 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-22 |
| Decision Date | 2014-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M719GCP4030 | K133245 | 000 |