510(k) K250908 ยท NKB Thoracolumbosacral Pedicle Screw System
Virata Spinal Fixation System
| Applicant | SeaSpine Orthopedics Corporation, Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 18, 2025 |
| Received | Mar 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250908
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2025 | Orthofix U.S. LLC Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected:
1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030.
2. POLYAXIAL S Open, Classified |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.