The following data is part of a premarket notification filed by U&i Corporation with the FDA for Facet Screw Fixation System.
| Device ID | K173198 |
| 510k Number | K173198 |
| Device Name: | Facet Screw Fixation System |
| Classification | System, Facet Screw Spinal Device |
| Applicant | U&i Corporation 20, Sandan-ro 76 Eon-gil(Rd) Uijeongbu-si, KR 11781 |
| Contact | Yeon-jung Choi |
| Correspondent | Yeon-jung Choi U&i Corporation 20, Sandan-ro 76 Eon-gil(Rd) Uijeongbu-si, KR 11781 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-02 |
| Decision Date | 2018-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800037500250 | K173198 | 000 |
| 08800015994774 | K173198 | 000 |
| 08800015994767 | K173198 | 000 |
| 08800015994750 | K173198 | 000 |
| 08800015994743 | K173198 | 000 |
| 08800015994736 | K173198 | 000 |
| 08800015994729 | K173198 | 000 |
| 08800015994712 | K173198 | 000 |
| 08800015994705 | K173198 | 000 |
| 08800015994699 | K173198 | 000 |
| 08800015994682 | K173198 | 000 |
| 08800015994781 | K173198 | 000 |
| 08800037500144 | K173198 | 000 |
| 08800037500243 | K173198 | 000 |
| 08800037500236 | K173198 | 000 |
| 08800037500229 | K173198 | 000 |
| 08800037500212 | K173198 | 000 |
| 08800037500205 | K173198 | 000 |
| 08800037500199 | K173198 | 000 |
| 08800037500182 | K173198 | 000 |
| 08800037500175 | K173198 | 000 |
| 08800037500168 | K173198 | 000 |
| 08800037500151 | K173198 | 000 |
| 08800015994675 | K173198 | 000 |