The following data is part of a premarket notification filed by Spineart with the FDA for Dynamik Intervertebral Body Fusion Device.
| Device ID | K081888 |
| 510k Number | K081888 |
| Device Name: | DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215 |
| Contact | Franck Pennesi |
| Correspondent | Franck Pennesi SPINEART COINTRIN 20 ROUTE DE PRE-BOIS CP1813 Geneva, CH 1215 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-02 |
| Decision Date | 2009-02-06 |
| Summary: | summary |