510(k) K020517 ยท MNI Orthosis, Spinal Pedicle Fixation
SYNTHES DUAL-OPENING USS
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Apr 15, 2002 |
| Received | Feb 19, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K020517
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2015 | Synthes (USA) Products LLC 5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm,
5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm,
5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, Terminated |
MNI | None listed |
| Aug 9, 2013 | Synthes USA HQ, Inc. 5.0mm Unit Rod 270mm
5.0mm Unit Rod 290mm
5.0mm Unit Rod 310mm
5.0mm Unit Rod 330mm
5.0mm Unit Rod 350mm
5.0mm Unit Rod 370mm
5.0mm Unit Rod 390mm
5.0mm Unit Rod 410mm
5.0mm Unit Rod 430mm
5.0mm Unit Terminated |
MNI | None listed |
| Jul 20, 2012 | Synthes (USA) Products LLC Universal Spinal System Lamina Hooks
Synthes Medium TI Lamina Hook - Right
498.320
Non sterile
LOT 6876785
Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterio Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.