The following data is part of a premarket notification filed by Altiva Corp. with the FDA for Contour Ii Spinal System.
| Device ID | K053070 |
| 510k Number | K053070 |
| Device Name: | CONTOUR II SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ALTIVA CORP. 9800-I SOUTHERN PINE BLVD. Charlotte, NC 28273 |
| Contact | John Kaptian |
| Correspondent | John Kaptian ALTIVA CORP. 9800-I SOUTHERN PINE BLVD. Charlotte, NC 28273 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-01 |
| Decision Date | 2006-02-13 |
| Summary: | summary |