The following data is part of a premarket notification filed by Wiltrom Corporation Limited with the FDA for Wiltrom Spinal Fixation System.
| Device ID | K172548 |
| 510k Number | K172548 |
| Device Name: | Wiltrom Spinal Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Wiltrom Corporation Limited 1F., No. 26, Sec. 2, Shengy Rd. Zhubei City, TW 30261 |
| Contact | Yi-chun Su |
| Correspondent | Yi-chun Su Wiltrom Corporation Limited 1F., No. 26, Sec. 2, Shengyi Rd. Zhubei City, TW 30261 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-23 |
| Decision Date | 2018-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719873024216 | K172548 | 000 |
| 04719873024223 | K172548 | 000 |