The following data is part of a premarket notification filed by Ionics Medical Corp. with the FDA for Dyn-alif Anterolateral Intervertebral Body Fusion Device.
| Device ID | K081673 |
| 510k Number | K081673 |
| Device Name: | DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | IONICS MEDICAL CORP. 248 BIRD HAVEN LN. Ether, NC 27247 -0179 |
| Contact | M. Laine Mashbum |
| Correspondent | M. Laine Mashbum IONICS MEDICAL CORP. 248 BIRD HAVEN LN. Ether, NC 27247 -0179 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-13 |
| Decision Date | 2008-11-14 |
| Summary: | summary |