The following data is part of a premarket notification filed by Acromed Corp. with the FDA for Isola System.
| Device ID | K952236 |
| 510k Number | K952236 |
| Device Name: | ISOLA SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Contact | Joyce Thomas |
| Correspondent | Joyce Thomas ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-12 |
| Decision Date | 1996-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034243191 | K952236 | 000 |
| 10705034243184 | K952236 | 000 |
| 10705034003627 | K952236 | 000 |