The following data is part of a premarket notification filed by Karen E. Warden, M.e.b.e. with the FDA for Gii Spinal Fixation System.
| Device ID | K980852 |
| 510k Number | K980852 |
| Device Name: | GII SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | KAREN E. WARDEN, M.E.B.E. 2249 ELM ST., SUITE 501 Cleveland, OH 44113 -2387 |
| Contact | Karen E Warden |
| Correspondent | Karen E Warden KAREN E. WARDEN, M.E.B.E. 2249 ELM ST., SUITE 501 Cleveland, OH 44113 -2387 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-05 |
| Decision Date | 1998-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640173162537 | K980852 | 000 |
| 07640173162452 | K980852 | 000 |
| 07640173162469 | K980852 | 000 |
| 07640173162476 | K980852 | 000 |
| 07640173162483 | K980852 | 000 |
| 07640173162490 | K980852 | 000 |
| 07640173162506 | K980852 | 000 |
| 07640173162513 | K980852 | 000 |
| 07640173162520 | K980852 | 000 |
| 07640173162445 | K980852 | 000 |