510(k) K142135 ยท HRS Plate, Fixation, Bone
REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION
| Applicant | Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic, Boonton NJ, US |
| Decision | Substantially Equivalent, Aug 28, 2014 |
| Received | Aug 4, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142135
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2018 | Orthofix, Inc Rival Reduce Kit Locking and Non-Locking Screw D 2.0MM, D 2.7MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-011C Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc Rival View Kit Locking and Non-Locking Screw D 2.7MM, D 3.2MM, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-009C Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc Box Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number): a) 18MM (003-F-18001);
b) 22MM (003-F-22001);
c) 30MM (003-F-30001) Terminated |
HRS | None listed |
| Jun 7, 2018 | Orthofix, Inc H-Plate, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Size (Part Number):
a) 12MM Spacer (003-H-12001);
b) 15MM Spacer (003-H-15001);
20MM Spacer (003-H-20001);
25MM Spacer (003-H-25001);
3 Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.