510(k) K173524 · NKB Thoracolumbosacral Pedicle Screw System
ANAX 5.5 Spinal System
| Applicant | U&I Corporation, Uijeongbu-Si, KR |
| Decision | Substantially Equivalent, Dec 13, 2017 |
| Received | Nov 14, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173524
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 26, 2020 | U&I CORP. ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.