510(k) K232566 ยท NKB Thoracolumbosacral Pedicle Screw System
NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System
| Applicant | SeaSpine Orthopedics Corporation, Carlsbad TX, US |
| Decision | Substantially Equivalent, Apr 19, 2024 |
| Received | Aug 24, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232566
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2024 | SEASPINE ORTHOPEDICS CORPORATION Brand Name: Daytona Small Stature
Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT
Model/Catalog Number: 79-0002
Software Version: N/A
Product Description: Locking Cap
Component: No Open, Classified |
NKB | None listed |
| Dec 23, 2024 | SEASPINE ORTHOPEDICS CORPORATION Brand Name: Daytona Small Stature
Product Name: Ti Locking Cap 4.5mm, Small Stature, T25
Model/Catalog Number: 79-0001
Software Version: N/A
Product Description: Locking Cap
Component: No Open, Classified |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.