510(k) K022325 ยท HRS Plate, Fixation, Bone
NORMED TITANIUM OSTEOTOMY PLATING SYSTEM
| Applicant | Osteomedics, Inc., Paramus NJ, US |
| Decision | Substantially Equivalent, Sep 9, 2002 |
| Received | Jul 17, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K022325
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2009 | Ascension Orthopedics, Inc Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascension Orthopedics, Inc., Austin, TX 78754.
Orthopedic manual surgical screwdriv Terminated |
HXX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.