The following data is part of a premarket notification filed by Grafton Medical Alliance with the FDA for Gma 2.0 Pedicle Screw System.
| Device ID | K192915 |
| 510k Number | K192915 |
| Device Name: | GMA 2.0 Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Grafton Medical Alliance 7416 Country Line Road Suite E Burr Ridge, IL 60527 |
| Contact | James Henry |
| Correspondent | Cassie Sopko JALEX Medical 27865 Clemens Rd Suite 3 Westlake, OH 44145 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-15 |
| Decision Date | 2019-11-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810021380469 | K192915 | 000 |
| 00810021380452 | K192915 | 000 |
| 00810021380445 | K192915 | 000 |
| 00810021380438 | K192915 | 000 |
| 00810021380421 | K192915 | 000 |