Medical device manufacturer
Wrightmedicaltechnologyinc
Wrightmedicaltechnologyinc holds 302 FDA 510(k) clearances across 45 product codes. Median elapsed review time is 87 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 302
- Product codes
- 45
- Median review
- 87 days
- Recall records
- 0
How does FDA spell Wrightmedicaltechnologyinc?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Wrightmedicaltechnologyinc file in?
45 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | 45 | 85 days | |
| HWC | Screw, Fixation, Bone | 31 | 66 days | |
| MQV | Filler, Bone Void, Calcium Compound | 28 | 90 days | |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 26 | 86 days | |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 21 | 141 days | |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 20 | 89 days | |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 12 | 64 days | |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 11 | 86 days | |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 11 | 61 days | |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 11 | 90 days | |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 11 | 81 days | |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 8 | 161 days | |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 7 | 87 days | |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 6 | 84 days | |
| HSB | Rod, Fixation, Intramedullary And Accessories | 6 | 37 days | |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 4 | 88 days | |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 4 | 132 days | |
| FMF | Syringe, Piston | 3 | 23 days | |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 3 | 139 days | |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 3 | 147 days | |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 2 | 20 days | |
| HTY | Pin, Fixation, Smooth | 2 | 37 days | |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | 2 | 90 days | |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 | 72 days | |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 2 | 63 days |
Showing the 25 they file in most, of 45.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Wrightmedicaltechnologyinc had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Wrightmedicaltechnologyinc cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K222835 | Prophecy Preoperative Navigation Alignment System | HSN | 129 | |
| K213342 | PRO-DENSE LoVisc Bone Graft Substitute | MQV | 90 | |
| K212996 | Sterile PHALINX Hammertoe System | HWC | 57 | |
| K202815 | PROPHECY Preoperative Navigation Alignment System | HSN | 167 | |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System | HRS | 242 | |
| K200507 | PRO-DENSE LoVisc Bone Graft Substitute | MQV | 233 | |
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System | HSN | 217 | |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | HSN | 90 | |
| K190970 | PROSTEP TBI (Tailors Bunion Implant) System | HWC | 123 | |
| K183620 | PROSTEP TBC Implant System | HRS | 162 |
Source: openFDA device/510k · retrieved
Watch what Wrightmedicaltechnologyinc files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
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