510(k) K070906 ยท HWC Screw, Fixation, Bone
MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, May 1, 2007 |
| Received | Apr 2, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070906
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fracture Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fracture Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fracture Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fracture Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 7-2357-018-04 Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fracture Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 47-2357-018-14 Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM, Sterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractu Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-017-06 Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-017-08 Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-017-10 Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-018-04 Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-018-06 Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-018-08 Open, Classified |
HWC | None listed |
| Apr 30, 2024 | Zimmer, Inc. ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal fixation and stabilization of osteotomies and fractures
Item Number: 00-2357-018-10 Open, Classified |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.