Montgomery® Thyroplasty Implant

Basic Information

• Brand Name: Montgomery® Thyroplasty Implant
• Primary DI: 14063107101783
• Version / Model: MTF-09
• Catalog Number: MTF-09
• Company Name: Boston Medical Products, Inc.
• Labeler DUNS: 131855157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-31
• Public Version: 1
• Public Version Date: 2022-09-08
• Public Version Status: New
• Public Device Record Key: c336148d-82ba-473a-ba83-8a3f34a9b5c8

Device Description

Size: Female 9

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MIX	System, Vocal Cord Medialization	Ear, Nose, Throat	874.3620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46942	Preformed vocal cord medialization implant	A solid, implantable device used for vocal cord medialization thyroplasty (removal of a "window" of cartilage from the outside of the voice box and replacing it with a prosthesis to push a paralyzed vocal cord toward the middle of the voice box) to treat patients with unilateral vocal cord paralysis to improve voice quality. It is available in a variety of shapes, materials [e.g., titanium (Ti), silicon, hydroxyapatite - also know as hydroxylapatite (HA)], and sizes (e.g., male and female). It can be adjusted intraoperatively to exactly fit the anatomic specifications of the patient, and may or may not be held in place with sutures.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	34063107101787	GS1	Carton	1	In Commercial Distribution
Primary	14063107101783	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K972317	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Size: Female 9

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry