The following data is part of a premarket notification filed by Printerprezz with the FDA for Gaia Lumbar Interbody Fusion Device (lifd) Family.
| Device ID | K201939 |
| 510k Number | K201939 |
| Device Name: | GAIA Lumbar Interbody Fusion Device (LIFD) Family |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | PrinterPrezz 4110 Clipper CT Fremont, CA 94538 |
| Contact | Kishore Karkera |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-13 |
| Decision Date | 2020-10-08 |