510(k) K143697 ยท HRS Plate, Fixation, Bone
Biomet Proximal Humerus Plating System
| Applicant | Biomet Manufacturing, Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 30, 2015 |
| Received | Dec 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143697
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
DRILL BLOCK SET SCREW, Item Number: 110017551 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during t Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM
DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures dur Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
PROXIMAL HUMERUS PLATE TEMPLATE 90MM,
Item Number: 110025471 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
PROXIMAL HUMERUS PLATE TEMPLATE 140MM
Item Number: 110025472 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and f Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
PROXIMAL HUMERUS PLATE TEMPLATE 234MM
Item Number: 110025473 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and f Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures d Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures d Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures d Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
HIGH PLATE LEFT 11 HOLE 197MM, Item Number: 110030308 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM
HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.