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Montgomery® Thyroplasty Implant

FDA UDI

Class II (US FDA UDI)

by Boston Medical Products, Inc.

Identity

Trade Name
Montgomery® Thyroplasty Implant FDA UDI
Generic Name
Preformed vocal cord medialization implant FDA UDI
Device Name
Size: Male 10 FDA UDI
Model / Reference
MTM-10 FDA UDI
Description
Size: Male 10 FDA UDI

Identifiers

Catalog Number
MTM-10 FDA UDI
Primary DI / UDI-DI
EBESMTM100 FDA UDI
510(k) Number
K972317 FDA UDI
FDA Product Code
MIX FDA UDI
GMDN Term
Preformed vocal cord medialization implant FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.3620 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Preformed vocal cord medialization implant

Montgomery® Thyroplasty Implant by Boston Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Preformed vocal cord medialization implant.

Cleared under the same submission

K972317 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Boston Medical Products, Inc.

Sources (1)

  • FDA UDI 74ea1acb-c40c-4833-afa8-f34a819270cd 38 fields · synced Jun 9, 2026