Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018282363

FEI Number

3018282363

Entity Name

ENSEMBLE ORTHOPEDICS, INC

City/State/Country

Austin, TX, US

Establishment Address

2621 Ridgepoint Drive, Ste 100, Austin, TX 78754, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ensemble Orthopedics, Inc (Owner Number: 10081216)

Owner / Operator Contact Address

2621 Ridgepoint Drive, Ste 100, Austin, TX 78754, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201072

PMA Number

N/A

All Registered Proprietary Names

Ensemble CMC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYI	Prosthesis, Wrist, Carpal Trapezium	Orthopedic	Class 2	888.3770	2021-03-25

Official Correspondent

Sandie Roth

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ensemble Orthopedics, Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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3010667733	WRIGHT MEDICAL TECHNOLOGY, INC.	Memphis, TN, US
3002807295	IONISOS	SABLE-SUR-SARTHE, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018282363. Last updated year: 2026. Please use registration number 3018282363 when referencing this establishment in official correspondence.