510(k) K150600 ยท NKB Thoracolumbosacral Pedicle Screw System
Response 5.5/6.0 Spine System
| Applicant | OrthoPediatrics Corp., Warsaw IL, US |
| Decision | Substantially Equivalent, May 22, 2015 |
| Received | Mar 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150600
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 6, 2020 | OrthoPediatrics Corp Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and
stabilization of the posterior, non-cervical spine in skeletally mature pati Open, Classified |
NKB | None listed |
| Aug 3, 2017 | OrthoPediatrics Corp Response 5.5/6.0 Spine System 7.0mm x 40mm
Pedicle Screw
Product Usage:
Posterior non-cervical pedicle screw fixation Terminated |
OSH | None listed |
| Nov 10, 2015 | OrthoPediatrics Corp UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw
The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.