Identity
- Trade Name
- Mpact 3D Metal Augments II FDA UDI
- Generic Name
- Acetabular augmentation implant FDA UDI
- Device Name
- Augments II Ø54 20mm FDA UDI
- Model / Reference
- 01.38.55420 FDA UDI
- Description
- Augments II Ø54 20mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630542700606 FDA UDI
- 510(k) Number
- K242232 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Acetabular augmentation implant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 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
Yes
FDA UDI
Category: Acetabular augmentation implant
Mpact 3D Metal Augments II by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetabular augmentation implant.
- REDAPT — Smith & Nephew, Inc. · Class II
- REDAPT — Smith & Nephew, Inc. · Class II
- REDAPT — Smith & Nephew, Inc. · Class II
- REDAPT — Smith & Nephew, Inc. · Class II
- TrabecuLink Augments — WALDEMAR LINK GmbH & Co. KG · Class II
- REDAPT — Smith & Nephew, Inc. · Class II
- REDAPT — Smith & Nephew, Inc. · Class II
- FREEDOM STEMMED — MAXX ORTHOPEDICS INC. · Class II
Cleared under the same submission
K242232 also covers:
- Mpact 3D Metal Augments II — Medacta International
- Mpact 3D Metal Augments II — Medacta International
- Mpact 3D Metal Augments II — Medacta International
- Mpact 3D Metal Augments II — Medacta International
- Mpact 3D Metal Augments II — Medacta International
- Mpact 3D Metal Augments II — Medacta International
- Mpact 3D Metal Augments II — Medacta International
- Mpact 3D Metal Augments II — Medacta International
- Mpact 3D Metal Augments II — Medacta International
- Mpact 3D Metal Augments II — Medacta International
- Mpact 3D Metal Augments II — Medacta International
- Mpact 3D Metal Augments II — 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 c80a34f4-5a68-4e6b-8183-6b9538498a4d 34 fields · synced Jun 1, 2026