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 |