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Thumb Tmc Md 19mm

FDA UDI

Class II (US FDA UDI)

by Biopro, Inc.

Identity

Trade Name
THUMB TMC MD 19MM FDA UDI
Generic Name
Carpometacarpal interpositional spacer, non-bioabsorbable FDA UDI
Model / Reference
14269 FDA UDI

Identifiers

Primary DI / UDI-DI
M209142690 FDA UDI
510(k) Number
K964472 FDA UDI
FDA Product Code
KYI FDA UDI
GMDN Term
Carpometacarpal interpositional spacer, non-bioabsorbable 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Carpometacarpal interpositional spacer, non-bioabsorbable

Thumb Tmc Md 19mm by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Carpometacarpal interpositional spacer, non-bioabsorbable.

Cleared under the same submission

K964472 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biopro, Inc.

Sources (1)

  • FDA UDI 9bf39fed-366a-496a-a949-cc46e207dd0b 33 fields · synced May 30, 2026