The following data is part of a premarket notification filed by Acromed Corp. with the FDA for Isola Spine System.
| Device ID | K944737 |
| 510k Number | K944737 |
| Device Name: | ISOLA SPINE SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Contact | Joyce Thoms |
| Correspondent | Joyce Thoms ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-26 |
| Decision Date | 1995-06-22 |