510(k) K161267 ยท OWI Bone Fixation Cerclage, Sublaminar
Response BandLoc Spinal Fixation
| Applicant | OrthoPediatrics Corp., Warsaw IN, US |
| Decision | Substantially Equivalent, Aug 11, 2016 |
| Received | May 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161267
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2017 | OrthoPediatrics Corp Response BandLoc 5.5/6.0 Tensioner Instrument
The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine m Terminated |
OWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.