FDA.reportPublic FDA data

Montgomery® Thyroplasty Implant

Primary DI
EBESMTM110
Brand
Montgomery® Thyroplasty Implant
Company
Boston Medical Products, Inc.
Model
MTM-11
Catalog number
MTM-11
Device description
Size: Male 11
Published
2015-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIXSystem, Vocal Cord Medialization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIXSystem, Vocal Cord MedializationEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972317000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972317000MONTGOMERY THYROPLASTY IMPLANT SYSTEMBoston Medical Products, Inc.1997-09-18MIX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBESMTM111PackageHIBCC1In Commercial Distribution
EBESMTM110PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Preformed vocal cord medialization implantA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-433-2674info@bosmed.com

Regulatory Flags#

DUNS number
131855157
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14063107102865Montgomery® Safe-T-Tube™ Plug/Ring Set3610863610862024-09-28
14063107102872Montgomery® Safe-T-Tube™ 15 mm Adaptor3610873610872024-09-28
14063107102889Montgomery® Safe-T-Tube™ Plug/Ring Set3611063611062024-09-28
14063107102896Montgomery® Safe-T-Tube™ 15 mm Adaptor3611073611072024-09-28
14063107102902Montgomery® Safe-T-Tube™ Plug/Ring Set3611163611162024-09-28
14063107102919Montgomery® Safe-T-Tube™ 15 mm Adaptor3611173611172024-09-28
14063107102926Montgomery® Safe-T-Tube™ Plug/Ring Set3611263611262024-09-28
14063107102933Montgomery® Safe-T-Tube™ 15 mm Adaptor3611273611272024-09-28
14063107102940Montgomery® Safe-T-Tube™ Plug/Ring Set3611463611462024-09-28
14063107102957Montgomery® Safe-T-Tube™ 15 mm Adaptor3611473611472024-09-28
14063107103060Montgomery® Safe-T-Tube™4600084600082024-09-28
14063107103077Montgomery® Safe-T-Tube™460008R460008R2024-09-28
14063107103084Montgomery® Safe-T-Tube™4600094600092024-09-28
14063107103091Montgomery® Safe-T-Tube™460009R460009R2024-09-28
14063107103107Montgomery® Safe-T-Tube™4600104600102024-09-28
14063107103114Montgomery® Safe-T-Tube™460010R460010R2024-09-28
14063107103121Montgomery® Safe-T-Tube™4600114600112024-09-28
14063107103138Montgomery® Safe-T-Tube™460011R460011R2024-09-28
14063107103145Montgomery® Safe-T-Tube™4600124600122024-09-28
14063107103152Montgomery® Safe-T-Tube™460012R460012R2024-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810235030846Prolaryn Gel MERZ NORTH AMERICA, INC.MIX2026-02-24
14063107101752Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101769Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101776Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101783Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101790Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101806Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101813Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101820Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101837Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101844Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101851Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101868Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107102629Montgomery® Thyroplasty Measuring KitBoston Medical Products, Inc.MIX2022-08-31
14063107102636Montgomery® Thyroplasty Measuring KitBoston Medical Products, Inc.MIX2022-08-31
34063107101756Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101763Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101770Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101787Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101794Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101800Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101817Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101824Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101831Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101848Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101855Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
34063107101862Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107102483Montgomery® Thyroplasty Instrument SetBoston Medical Products, Inc.MIX2022-08-31
14063107102490Montgomery® Thyroplasty InstrumentBoston Medical Products, Inc.MIX2022-08-31
14063107102506Montgomery® Thyroplasty InstrumentBoston Medical Products, Inc.MIX2022-08-31