Identity
- Trade Name
- Mpact 3D Metal FDA UDI
- Generic Name
- Metallic acetabulum prosthesis FDA UDI
- Device Name
- Augments 50/52 30mm FDA UDI
- Model / Reference
- 01.38.103 FDA UDI
- Description
- Augments 50/52 30mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630030889004 FDA UDI
- 510(k) Number
- K171966 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Metallic acetabulum prosthesis 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
No
FDA UDI
Category: Metallic acetabulum prosthesis
Mpact 3D Metal by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Metallic acetabulum prosthesis.
- TRABECULAR METAL™ — Zimmer Trabecular Metal Technology, Inc. · Class II
- Lineage — MicroPort Orthopedics Inc. · Class II
- Lineage — MicroPort Orthopedics Inc. · Class II
- Dynasty — MicroPort Orthopedics Inc. · Class II
- Platform Acetabular Cup with Ti-Coat — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- PRIME — MicroPort Orthopedics Inc. · Class II
- PROCOTYL® PRIME — MicroPort Orthopedics Inc. · Class II
- Lineage — MicroPort Orthopedics Inc. · Class II
Cleared under the same submission
K171966 also covers:
- Mpact 3D Metal — Medacta International
- Mpact 3D Metal — Medacta International
- Mpact 3D Metal — Medacta International
- Mpact 3D Metal — Medacta International
- Mpact 3D Metal — Medacta International
- Mpact 3D Metal — Medacta International
- Mpact 3D Metal — Medacta International
- Mpact 3D Metal — Medacta International
- Mpact 3D Metal — Medacta International
- Mpact 3D Metal — Medacta International
- Mpact 3D Metal — Medacta International
- Mpact 3D Metal — 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 f37a8017-a87a-43d9-974e-ff1706d45ace 34 fields · synced May 30, 2026