The following data is part of a premarket notification filed by Vertiflex, Inc. with the FDA for Vertiflex Direct Decompression System.
| Device ID | K122662 |
| 510k Number | K122662 |
| Device Name: | VERTIFLEX DIRECT DECOMPRESSION SYSTEM |
| Classification | Arthroscope |
| Applicant | VERTIFLEX, INC. 1351 Calle Avanzado San Clemente, CA 92673 |
| Contact | Steve Reitzler |
| Correspondent | Steve Reitzler VERTIFLEX, INC. 1351 Calle Avanzado San Clemente, CA 92673 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-31 |
| Decision Date | 2012-11-13 |
| Summary: | summary |