Identity
- Trade Name
- Mpact Acetabular System FDA UDI
- Generic Name
- Acetabulum prosthesis hole plug FDA UDI
- Device Name
- Mpact Shell screw plug FDA UDI
- Model / Reference
- 01.31.55TP FDA UDI
- Description
- Mpact Shell screw plug FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030860911 FDA UDI
- 510(k) Number
- K103721 FDA UDI
- FDA Product Code
- LPH FDA UDILZO FDA UDI
- GMDN Term
- Acetabulum prosthesis hole plug FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 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
Category: Acetabulum prosthesis hole plug
Mpact Acetabular System by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetabulum prosthesis hole plug.
- plug — implantcast GmbH · Class II
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- Trinity Acetabular Hip System — CORIN LTD · Class II
- Escalade Acetabular System — ORTHO DEVELOPMENT CORP. · Class II
- Continuum® — Zimmer, Inc. · Class II
- ORTHOLOC™ 2 Jones Fracture System — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- Converge® — Zimmer, Inc. · Class II
- R3 — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K103721 also covers:
- CoCr Femoral Ball Head — Medacta International
- CoCr Femoral Ball Head — Medacta International
- CoCr Femoral Ball Head — Medacta International
- CoCr Femoral Ball Head — Medacta International
- Mpact Acetabular System — Medacta International
- Mpact Acetabular System — Medacta International
- Mpact Acetabular System — Medacta International
- Mpact Acetabular System — Medacta International
- Mpact Acetabular System — Medacta International
- Mpact Acetabular System — Medacta International
- Mpact Acetabular System — Medacta International
- Mpact Acetabular System — Medacta International
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 |
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Manufacturer
- Manufacturer
- Medacta International
Sources (1)
- FDA UDI 19efe9dd-b755-433c-91e1-2e6177c03781 34 fields · synced May 30, 2026