510(k) K193396 · NKB Thoracolumbosacral Pedicle Screw System
PERLA® TL posterior osteosynthesis system
| Applicant | Spineart, Plan Les Ouates, CH |
| Decision | Substantially Equivalent, Feb 5, 2020 |
| Received | Dec 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193396
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2024 | SPINEART SA PERLA TL 25D SCREW REF:
TLF-DS 45 25-S
TLF-DS 45 30-S
TLF-DS 45 35-S
TLF-DS 45 40-S
TLF-DS 45 45-S
TLF-DS 55 30-S
TLF-DS 55 35-S
TLF-DS 55 40-S
TLF-DS 55 45-S
TLF-DS 65 35-S
TLF-DS 65 40-S
TLF-DS 65 Open, Classified |
NKB | None listed |
| Apr 9, 2021 | SPINEART SA PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Models:
PERLA TL Lateral Con Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.