The following data is part of a premarket notification filed by Acromed Corp. with the FDA for Isola Spinal System.
| Device ID | K980485 |
| 510k Number | K980485 |
| Device Name: | ISOLA SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Contact | William Christianson |
| Correspondent | William Christianson ACROMED CORP. 3303 CARNEGIE AVE. Cleveland, OH 44115 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-09 |
| Decision Date | 1998-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034003405 | K980485 | 000 |
| 10705034004525 | K980485 | 000 |
| 10705034242200 | K980485 | 000 |
| 10705034242132 | K980485 | 000 |
| 10705034241715 | K980485 | 000 |
| 10705034241708 | K980485 | 000 |
| 10705034240640 | K980485 | 000 |
| 10705034011356 | K980485 | 000 |
| 10705034004570 | K980485 | 000 |
| 10705034004563 | K980485 | 000 |
| 10705034004556 | K980485 | 000 |
| 10705034004549 | K980485 | 000 |
| 10705034004532 | K980485 | 000 |
| 10705034003245 | K980485 | 000 |
| 10705034000930 | K980485 | 000 |
| 10705034003252 | K980485 | 000 |
| 10705034003399 | K980485 | 000 |
| 10705034011295 | K980485 | 000 |
| 10705034005782 | K980485 | 000 |
| 10705034005737 | K980485 | 000 |
| 10705034156460 | K980485 | 000 |
| 10705034012940 | K980485 | 000 |
| 10705034012919 | K980485 | 000 |
| 10705034011400 | K980485 | 000 |
| 10705034011394 | K980485 | 000 |
| 10705034011370 | K980485 | 000 |
| 10705034241524 | K980485 | 000 |
| 10705034003276 | K980485 | 000 |
| 10705034003269 | K980485 | 000 |
| 10705034000947 | K980485 | 000 |