The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Palladian Lumbar Pedicle Screw System.
Device ID | K143230 |
510k Number | K143230 |
Device Name: | Palladian Lumbar Pedicle Screw System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | Neurostructures, Inc. 16 Technology Dr. Suite 165 Irvine, CA 32918 |
Contact | Moti Altarac |
Correspondent | Meredith L May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-10 |
Decision Date | 2015-02-25 |
Summary: | summary |