510(k) K140876 ยท HRS Plate, Fixation, Bone
VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW
| Applicant | Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic, Boonton NJ, US |
| Decision | Substantially Equivalent, Jul 22, 2014 |
| Received | Apr 7, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140876
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2018 | Orthofix, Inc Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (0002-D-20008); b) D 2.0MM X 10MM (002-D-20010);
c) D 2.0MM X 12MM (002-D-20012);
d) D 2.0MM Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc Locking Screw, D 2.0MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label. Size (Part Number): a) D 2.0MM X 8MM (002-E-20008); b) D 2.0MM X 10MM (002-E-20010);
c) D 2.0MM X 12MM (002-E-20012);
Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc Non-Locking Screw, D 2.7MM X 8MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Numbers): a) D 2.7MM X 8MM (002-D-27008);
b) D 2.7MM X 10MM (002-D-27010);
c) D 2.7MM X 12MM (002-D-270 Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 2.7MM X 8MM (002-E-27008),
b) D 2.7MM X 10MM (002-E-27010);
c) D 2.7MM X 12MM (002-E-27012);
d) D 2.7MM X 14MM Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc Non-Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a)D 3.2MM X 10MM (002-D-32010)
b) D 3.2MM X 12MM (002-D-32012)
c) D 3.2MM X 14MM (002-D-32014)
d) D 3.2MM X 16M Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc Locking Screw, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) D 3.2MM X 10MM (002-E-32010)
b) D 3.2MM X 12MM (002-E-32012)
c) D 3.2MM X 14MM (002-E-32014)
d) D 3.2MM X 16MM ( Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc CC Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-G-01020);
b) Medium (002-G-01025);
c) Large (002-G-01030) Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc Evans Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 6MM Spacer (002-H-00006);
b) 8MM Spacer (022-H-00008);
c) 10MM Spacer (002-H-00010);
d) 12MM Spacer (002-H-0001 Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc Lapidus Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size/Step/Left or Right (Part Number):
a) Small/0MM Step/Left (002-C-01000L);
b) Small/0MM Step/Right (002-C-01000R);
c) Large/0MM St Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc L-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Left or Right (Part Number): a) Left (003-E-00001L); b) Right (003-E-00001R) Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc MTP Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-B-01001); b) Medium (002-B-02002);
c) Large (002-B-03003) Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc Straight Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Holes (Part Number): a) 3 Hole (003-D-01001); b) 4 Hole (003-D-02001); c) 6 Hole (003-D-03001) Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc TN Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (002-F-01020); b) Medium (002-F-01025);
c) Large (002-F-01030) Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc T-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-B-01001); b) Large (003-B-02001) Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc Y-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) Small (003-C-01001); b) Large (003-C-02001) Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.