510(k) K073375 ยท HRS Plate, Fixation, Bone
NEWDEAL TIBIAXYS SYSTEM
| Applicant | Newdeal Sas, Planisboro NJ, US |
| Decision | Substantially Equivalent, Feb 21, 2008 |
| Received | Dec 3, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073375
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2022 | Smith & Nephew, Inc. INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND Open, Classified |
HRS | None listed |
| Jun 2, 2014 | Integra LifeSciences Corporation Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.