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 |