Identity
- Trade Name
- MTP Trial FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- TMC MTP Trial, 5mm FDA UDI
- Model / Reference
- 02-00318 FDA UDI
- Description
- TMC MTP Trial, 5mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810111224123 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Surgical implant/trial-implant/sizer holder, reusable
The MTP Trial is a hand-held manual surgical instrument designed to connect to and hold an implant, trial implant, or implantable device sizer/template during orthopaedic surgery. Made of metal or synthetic polymer materials, it's typically constructed in the form of a long shaft with a handle at one end and a device holding/fixation mechanism at the other. The MTP Trial is reusable, featuring 5mm diameter, for medical professionals to ensure accurate implant sizing and guidance.
Similar devices
Also classified as Surgical implant/trial-implant/sizer holder, reusable.
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- TALOS® (HA) IBF — MEDITECH SPINE, LLC · Class II
- BENCOX THR System — Corentec Co., Ltd · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Treace Medical Concepts, Inc.
Sources (1)
- FDA UDI 9dd7e68d-811b-40e2-8f36-bf0959b65ca1 33 fields · synced Jul 7, 2026