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TMINI™ Guide Block Kit for Enovis™ EMPOWR Knee System®

FDA UDI

Class II (US FDA UDI)

by Think Surgical Inc.

Identity

Trade Name
TMINI™ Guide Block Kit for Enovis™ EMPOWR Knee System® FDA UDI
Generic Name
Total knee prosthesis implantation guide-instrument kit FDA UDI
Model / Reference
109421 FDA UDI

Identifiers

Catalog Number
109421 FDA UDI
Primary DI / UDI-DI
M9461094211 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Total knee prosthesis implantation guide-instrument kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Category: Total knee prosthesis implantation guide-instrument kit

TMINI™ Guide Block Kit for Enovis™ EMPOWR Knee System® by Think Surgical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Total knee prosthesis implantation guide-instrument kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Think Surgical Inc.

Sources (1)

  • FDA UDI 15a1709c-5c7b-49e8-9750-141a662c49bf 34 fields · synced May 30, 2026