Data / Medical devices / United States / Ensemble Orthopedics, Inc
Ensemble Orthopedics, Inc: FDA-registered device maker in Austin, TX, United States, 1 510(k) clearance
Ensemble Orthopedics, Inc is registered with the FDA (registration 3018282363) in Austin, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 2, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018282363
- Address
- 2621 Ridgepoint Drive Ste 100, Austin, TX, United States, 78754
- Owner or operator
- Ensemble Orthopedics, Inc (10081216)
- Roles
- Manufacturer
- First device listed
- March 25, 2021
- Registered through
- 2026
- Brand names listed
- Ensemble CMC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Wrist, Carpal Trapezium | KYI | 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 |
|---|---|---|---|---|---|---|
| December 2, 2020 | K201072 | Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 | KYI | Substantially Equivalent | Ensemble Orthopedics, LLC | accessdata.fda.gov |
Compare with other makers
Updated December 2, 2020. 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.