The following data is part of a premarket notification filed by Vertiflex, Inc. with the FDA for Vertiflex Spinous Process Fixation Plate.
| Device ID | K122509 |
| 510k Number | K122509 |
| Device Name: | VERTIFLEX SPINOUS PROCESS FIXATION PLATE |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | VERTIFLEX, INC. 1351 CALLE AVANZADO San Clamente, CA 92673 |
| Contact | Steve Reitzler |
| Correspondent | Steve Reitzler VERTIFLEX, INC. 1351 CALLE AVANZADO San Clamente, CA 92673 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-17 |
| Decision Date | 2012-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327065657 | K122509 | 000 |
| 07613327065640 | K122509 | 000 |