510(k) K051310 ยท HWC Screw, Fixation, Bone
PLC SCREW
| Applicant | Smith & Nephew, Inc., Andover MA, US |
| Decision | Substantially Equivalent, Jul 26, 2005 |
| Received | May 19, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051310
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 20 mm,
P/N 7211109, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 6 mm x 25 mm,
P/N 7211110, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 6 mm x 25 mm,
P/N 7211111, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 20 mm,
P/N 7211112, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 25 mm,
P/N 7211113, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 7 mm x 25 mm,
P/N 7211114, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 7 mm x 30 mm,
P/N 7211115, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 25 mm,
P/N 7211116, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 30 mm,
P/N 7211117, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 35 mm,
P/N 7211118, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 25 mm,
P/N 7211119, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 30 mm,
P/N 7211120, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 35 mm,
P/N 7211121, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 25 mm,
P/N 7211122, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 30 mm,
P/N 7211123, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 35 mm,
P/N 7211124, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 30 mm,
P/N 7211125, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 35 mm,
P/N 7211126, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 12 mm x 35 mm,
P/N 7211127, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 8 mm x 20 mm,
P/N 72201069, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 9 mm x 20 mm,
P/N 72201070, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 10 mm x 20 mm,
P/N 72201071, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, 11 mm x 25 mm,
P/N 72201072, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
| Mar 19, 2008 | Smith & Nephew, Inc. Endoscopy Division Smith & Nephew, CALAXO Bioabsorbable lnterference Screw, Reverse Thread, 8 mm x 25 mm,
P/N 72201073, Ligament Screw, Smith & Nephew, Endoscopy Division, Andover, MA 01810 Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.