The following data is part of a premarket notification filed by Surgtech Inc. with the FDA for Surgtech Thoracolumbosacral (tls) Posterior Fixation System.
Device ID | K163363 |
510k Number | K163363 |
Device Name: | SurgTech Thoracolumbosacral (TLS) Posterior Fixation System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | SurgTech Inc. 24600 Center Ridge Road, Suite 195 Westlake, OH 44145 |
Contact | Xuegong Yu |
Correspondent | Karen E. Warden, Ph.d. BackRoads Consulting Inc. P.O. Box 566 Chesterland, OH 44026 |
Product Code | NKB |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-30 |
Decision Date | 2017-04-05 |
Summary: | summary |