510(k) K182550 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Wireless Digital Flat Panel Detector
| Applicant | Iray Technology Taicang , Ltd., Taicang, CN |
| Decision | Substantially Equivalent, Oct 17, 2018 |
| Received | Sep 17, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182550
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 4.5X45MM, Item Number 810M4545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
| May 5, 2020 | Zimmer Biomet, Inc. Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM, Item Number 810M5540 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, post Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.