510(k) K822780 ยท JEC Component, Traction, Invasive
CERVICAL BRACE
| Applicant | Jerome Medical, Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 6, 1982 |
| Received | Sep 14, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K822780
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2018 | Ossur Americas Ossur Skull Pin, Sterile Titanium Pin,
Part/Description:
516TS/ Skull Pin 2-1/4in TI Sterl 1PK;
516V2S/ Skull Pin 3in TI Sterl 1PK;
520TS/ Skull Pin 2-1/4in TI Sterl 5PK;
520V2S/ Skull Pin 3in TI St Terminated |
JEC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.