Data / Medical devices / United States / Unik Orthopedics, Inc
Unik Orthopedics, Inc: FDA-registered device maker in San Jose, CA, United States, 3 510(k) clearances
Unik Orthopedics, Inc is registered with the FDA (registration 3019006180) in San Jose, CA, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 27, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3019006180
- Address
- 1701 Fortune Drive Suite E, San Jose, CA, United States, 95131
- Owner or operator
- Unik Orthopedics, Inc (10081722)
- Roles
- Manufacturer
- First device listed
- May 10, 2021
- Registered through
- 2027
- Brand names listed
- UNIKO PointCloud Knee Instruments, Vault System Surgery Planning Software
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Knee Arthroplasty Implantation System | OOG | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 27, 2024 | K240327 | UNIKO PointCloud Knee Instruments | JWH | Substantially Equivalent | Unik Orthopedics, Inc. | accessdata.fda.gov |
| August 12, 2020 | K193312 | UNIKO PointCloud Knee Instruments | MBH | Substantially Equivalent | Unik Orthopedics, Inc. | accessdata.fda.gov |
| May 17, 2013 | K124051 | THE VAULT SYSTEM | LLZ | Substantially Equivalent | Somersault Orthopedics, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- All makers of Knee Arthroplasty Implantation System
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of System, Image Processing, Radiological
Updated June 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.