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Ensemble CMC

FDA UDI

Class II (US FDA UDI)

by Ensemble Orthopedics, LLC

Identity

Trade Name
Ensemble CMC FDA UDI
Generic Name
Metacarpal prosthesis FDA UDI
Model / Reference
Ensemble CMC Trial, Size 141 FDA UDI

Identifiers

Catalog Number
103-TRL-141 FDA UDI
Primary DI / UDI-DI
00810063560058 FDA UDI
510(k) Number
K201072 FDA UDI
FDA Product Code
KYI FDA UDI
GMDN Term
Metacarpal prosthesis FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3770 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Metacarpal prosthesis

Ensemble CMC by Ensemble Orthopedics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metacarpal prosthesis.

Cleared under the same submission

K201072 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ensemble Orthopedics, LLC

Sources (1)

  • FDA UDI a8954e3a-0a13-4669-943d-5ec3c69c3751 35 fields · synced Jun 8, 2026