Identity
- Trade Name
- Montgomery® Thyroplasty Implant Set FDA UDI
- Generic Name
- Preformed vocal cord medialization implant FDA UDI
- Device Name
- Type: Combination. Contains one each of MTF-06, MTF-07, MTM-08, & MTM-09. Contains two each of MTF-08, MTF-09, MTF-10, MTM-10, MTM-11, & MTM-12. FDA UDI
- Model / Reference
- MTC-01 FDA UDI
- Description
- Type: Combination. Contains one each of MTF-06, MTF-07, MTM-08, & MTM-09. Contains two each of MTF-08, MTF-09, MTF-10, MTM-10, MTM-11, & MTM-12. FDA UDI
Identifiers
- Catalog Number
- MTC-01 FDA UDI
- Primary DI / UDI-DI
- EBESMTC011 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Preformed vocal cord medialization implant
Montgomery® Thyroplasty Implant Set 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.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc. · Class II
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc. · Class II
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc. · Class II
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc. · Class II
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc. · Class II
- Montgomery® Thyroplasty Implant Set — Boston Medical Products, Inc. · Class II
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc. · Class II
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc. · Class II
Cleared under the same submission
K972317 also covers:
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
- Montgomery® Thyroplasty Implant — Boston Medical Products, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Boston Medical Products, Inc.
Sources (1)
- FDA UDI 609f0fc1-e340-4c28-926d-02562f5f4910 37 fields · synced Jun 9, 2026