510(k) K140891 ยท HWC Screw, Fixation, Bone
BIOMET CANNULATED SCREW SYSTEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jun 3, 2014 |
| Received | Apr 8, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140891
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2020 | Biomet, Inc. 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810,
110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, smal Terminated |
HWC | None listed |
| Dec 17, 2020 | Biomet, Inc. 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009929,
110009934, 110009935, 110009936, 110009993, 110009994,
110009996, 110009998, 1100100 Terminated |
HWC | None listed |
| May 14, 2020 | Biomet Biomet 6.5 Cannulated Screw Tap - Bone fixation screw,
Item Number: 110008466 - Product Usage:
Intended for temporary internal fixation and stabilization of osteotomies and fractures during the nor Terminated |
HWC | None listed |
| May 14, 2020 | Biomet Biomet 8.0 Cannulated Screw Tap-Bone fixation screw
Item Number: 110008467 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal he Terminated |
HWC | None listed |
| Dec 7, 2017 | Zimmer Biomet, Inc. 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910)
Product Usage:
The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated sc Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.