The following data is part of a premarket notification filed by Acromed Corp. with the FDA for Isola(tm) Spine System--eye Rod.
| Device ID | K911394 |
| 510k Number | K911394 |
| Device Name: | ISOLA(TM) SPINE SYSTEM--EYE ROD |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Contact | Rosemary H Zang |
| Correspondent | Rosemary H Zang ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-29 |
| Decision Date | 1991-06-21 |