The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Modification To Isola Spinal System.
| Device ID | K993030 |
| 510k Number | K993030 |
| Device Name: | MODIFICATION TO ISOLA SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Frank Maas |
| Correspondent | Frank Maas DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | KWQ |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-07 |
| Decision Date | 1999-12-29 |
| Summary: | summary |