Identity
- Trade Name
- Mpact DM Converter FDA UDI
- Generic Name
- Metallic acetabular liner FDA UDI
- Device Name
- Double Mobility Converter Liner D/DMB FDA UDI
- Model / Reference
- 01.32.3641MC FDA UDI
- Description
- Double Mobility Converter Liner D/DMB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030812095 FDA UDI
- 510(k) Number
- K131458 FDA UDI
- FDA Product Code
- MEH FDA UDILZO FDA UDI
- GMDN Term
- Metallic acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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: Metallic acetabular liner
Mpact DM Converter by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic acetabular liner.
- EMPHASYS — DEPUY (IRELAND) · Class II
- Micro Seal Shell — Signal Medical Corp. · Class II
- Micro Seal Shell — Signal Medical Corp. · Class II
- Logical Dual Mobility CoCr Liner — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- OR3O Dual Mobility — Smith & Nephew, Inc. · Class II
- EMPHASYS — DEPUY (IRELAND) · Class II
- Micro Seal Shell — Signal Medical Corp. · Class II
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
Cleared under the same submission
K131458 also covers:
- Double Mobility Liner — Medacta International
- Double Mobility Liner — Medacta International
- Mpact DM Converter — Medacta International
- Mpact DM Converter — Medacta International
- Mpact DM Converter — Medacta International
- Mpact DM Converter — Medacta International
- Mpact DM Converter — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medacta International
Sources (1)
- FDA UDI 33b8c475-ee9f-4d9b-a73b-741b6f1d42f8 34 fields · synced Jun 8, 2026