510(k) K203506 · NKB Thoracolumbosacral Pedicle Screw System
PERLA® TL posterior osteosynthesis system
| Applicant | Spineart, Plan Les Ouates, CH |
| Decision | Substantially Equivalent, Jan 15, 2021 |
| Received | Nov 30, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203506
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2025 | SPINEART SA Brand Name: PERLA TL MIS
Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW
Model/Catalog Number: MPF-PS 65 40-S
Software Version: Not Applicable
Product Description: CANNULATED FENESTRATED POLYAXI Open, Classified |
NKB | None listed |
| Aug 8, 2025 | SPINEART SA Brand Name: PERLA TL MIS
Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW
Model/Catalog Number: MPF-PS 55 45-S
Software Version: Not Applicable
Product Description: CANNULATED FENESTRATED POLYAXI Open, Classified |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.