The following data is part of a premarket notification filed by Ionics Medical Corp. with the FDA for Ionics Levante Intervertebral Pillar, Expandable.
| Device ID | K983667 |
| 510k Number | K983667 |
| Device Name: | IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | IONICS MEDICAL CORP. 702 13TH ST., #108 Miami Beach, FL 33139 |
| Contact | M. Laine Mashburn |
| Correspondent | M. Laine Mashburn IONICS MEDICAL CORP. 702 13TH ST., #108 Miami Beach, FL 33139 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-19 |
| Decision Date | 2000-07-05 |