510(k) K190376 ยท NKB Thoracolumbosacral Pedicle Screw System
PASS LP Spinal System
| Applicant | Medicrea International SA, Rillieux-La-Pape, FR |
| Decision | Substantially Equivalent, May 2, 2019 |
| Received | Feb 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190376
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2020 | Medicrea International Pedicle Screws, multiple sizes,
Article Nos. B36004525
B36004530
B36004535
B36004540
B36004545
B36004550
B36004555
B36005530
B36005535
B36005540
B36005545
B36005550
B36005555
B36005560
B36006530
B360 Terminated |
KWP | None listed |
| Jan 28, 2020 | Medicrea International Iliac Screws, multiple sizes,
Article Nos. B36020500
B36020570
B36020580
B36020590
B36027500
B36027570
B36027580
B36027590
B36028500
B36028570
B36028580
B36028590
B36029500
B36029570
B36029580
B36029 Terminated |
KWP | None listed |
| Nov 11, 2019 | Medicrea International Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System
Ref : A22020500 Terminated |
NKB | None listed |
| Sep 16, 2019 | Medicrea International Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol
Product reference : A06010130 Open, Classified |
KWP | None listed |
| Sep 16, 2019 | Medicrea International Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol
Product reference: A06010140 Open, Classified |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.