The following data is part of a premarket notification filed by Altiva Corp. with the FDA for Hydralok System.
| Device ID | K051216 |
| 510k Number | K051216 |
| Device Name: | HYDRALOK SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ALTIVA CORP. 9800-I SOUTHERN PINE BLVD. Charlotte, NC 28273 |
| Contact | John Kapitan |
| Correspondent | John Kapitan ALTIVA CORP. 9800-I SOUTHERN PINE BLVD. Charlotte, NC 28273 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-12 |
| Decision Date | 2005-07-19 |
| Summary: | summary |