Panels › Orthopedic › Product code PLF · Class 2
Bone Wedge
Regulation 888.3030
1510(k)s in 12 months (18 all time)
2recalls in 12 months (9 all time)
7recalls that name a 510(k)
Top companies in PLF
| Company | 510(k)s | Recalls |
|---|---|---|
| Nvision Biomedical Technologies | 7 | 0 |
| Arthrex, Inc. | 0 | 6 |
| Paragon 28 | 2 | 3 |
| Tyber Medical, LLC | 2 | 0 |
| Additive Device, Inc. (Adi) D/B/A Restor3D | 1 | 0 |
| Ames Medical Prosthetic Solutions, S.A.U. | 1 | 0 |
| Arthex, Inc. | 1 | 0 |
| Auxano Medical, LLC | 1 | 0 |
| MiRus, LLC | 1 | 0 |
| Restor3D, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Paragon 28, Inc. Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant Open, Classified |
PLF | None listed |
| Aug 14, 2026 | Paragon 28, Inc. Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant Open, Classified |
PLF | None listed |
| Dec 10, 2019 | Paragon 28, Inc. P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only Terminated |
PLF | K162241 |
| Apr 22, 2016 | Arthrex, Inc. BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. Terminated |
PLF | K151256 |
| Apr 22, 2016 | Arthrex, Inc. BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. Terminated |
PLF | K151256 |
| Apr 22, 2016 | Arthrex, Inc. BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. Terminated |
PLF | K151256 |
| Apr 22, 2016 | Arthrex, Inc. BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. Terminated |
PLF | K151256 |
| Apr 22, 2016 | Arthrex, Inc. BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. Terminated |
PLF | K151256 |
| Apr 22, 2016 | Arthrex, Inc. BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. Terminated |
PLF | K151256 |
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