The following data is part of a premarket notification filed by Tdm Co. Ltd. with the FDA for Pine Pedicle Screw System.
| Device ID | K220285 |
| 510k Number | K220285 |
| Device Name: | PINE Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | TDM Co. Ltd. 69, Cheomdan Venture So-ro, 37 Beon-gil, Buk-gu Gwangju, KR 61003 |
| Contact | Choi Jung Wook |
| Correspondent | Jeena Mathai Eerkie Corporation 4027 Runnymeade Dr Collegeville, PA 19426 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-01 |
| Decision Date | 2022-05-19 |