510(k) K040363 ยท LYT Fixation Accessory
CERAMIC TIPPED SKULL PIN
| Applicant | The Jerome Group, Inc., Moorestown NJ, US |
| Decision | Substantially Equivalent, Apr 12, 2004 |
| Received | Feb 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040363
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 21, 2018 | Ossur Americas Ossur Skull Pin, Sterile Ceramic Tip Pin,
Part/ Description:
516CS/ Skull Pin 2-1/4in CT Sterl 1PK;
516DS/ Skull Pin 3in CT Sterl 1PK;
517CS/ Skull Pin 2-1/4in CT Sterl 4PK;
517DS/ Skull Pin 3in CT Terminated |
LYT | None listed |
| Jan 2, 2009 | Ossur Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S Terminated |
LYT | None listed |
| Jan 2, 2009 | Ossur Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS Terminated |
LYT | None listed |
| Jan 2, 2009 | Ossur Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS Terminated |
LYT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.