Medical device manufacturer
Osteonics Corp.
Osteonics Corp. holds 178 FDA 510(k) clearances across 30 product codes. Median elapsed review time is 84 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 178
- Product codes
- 30
- Median review
- 84 days
- Recall records
- 0
How does FDA spell Osteonics Corp.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Osteonics Corp. file in?
30 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 29 | 79 days | |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 24 | 90 days | |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 24 | 109 days | |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 10 | 84 days | |
| HWC | Screw, Fixation, Bone | 8 | 61 days | |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 8 | 62 days | |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 7 | 78 days | |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 7 | 195 days | |
| HRS | Plate, Fixation, Bone | 6 | 76 days | |
| JDK | Prosthesis, Hip, Cement Restrictor | 6 | 72 days | |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 6 | 61 days | |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 5 | 80 days | |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 4 | 90 days | |
| HSB | Rod, Fixation, Intramedullary And Accessories | 4 | 34 days | |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 3 | 83 days | |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 3 | 90 days | |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 3 | 70 days | |
| KWP | Appliance, Fixation, Spinal Interlaminal | 3 | 144 days | |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 2 | 57 days | |
| JDJ | Mesh, Surgical, Acetabular, Hip, Prosthesis | 2 | 78 days | |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 2 | 38 days | |
| FWW | Table, Operating-Room, Pneumatic | 1 | 99 days | |
| HTY | Pin, Fixation, Smooth | 1 | 75 days | |
| JDQ | Cerclage, Fixation | 1 | 66 days | |
| JDR | Staple, Fixation, Bone | 1 | 22 days |
Showing the 25 they file in most, of 30.
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 Osteonics Corp. 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 Osteonics Corp. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K983657 | OSTEONICS SERIES 7000 AD TIBIAL TRAY | HRY | 535 | |
| K980070 | OSTEONICS HA-COATED DEVICES | MEH | 561 | |
| K984375 | OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY | KWP | 144 | |
| K982798 | OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM | KWQ | 227 | |
| K984585 | OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE | KWL | 62 | |
| K990203 | OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS | MEH | 28 | |
| K990158 | OSTEONICS COMBINATION SCREW RING/BLOCKER | MNI | 13 | |
| K984302 | OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS | MNH | 16 | |
| K984353 | OSTEO 9MM IC TIBIAL NAIL | HSB | 9 | |
| K983502 | OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM | LPH | 71 |
Source: openFDA device/510k · retrieved
Watch what Osteonics Corp. files next
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