Identity
- Trade Name
- AMIStem-P FDA UDI
- Generic Name
- Press-fit hip femur prosthesis, one-piece FDA UDI
- Device Name
- AMIStem-P STD stem #0 FDA UDI
- Model / Reference
- 01.18.400 FDA UDI
- Description
- AMIStem-P STD stem #0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630040719995 FDA UDI
- 510(k) Number
- K173794 FDA UDI
- FDA Product Code
- LPH FDA UDILZY FDA UDIKWY FDA UDIMEH FDA UDILZO FDA UDI
- GMDN Term
- Press-fit hip femur prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3360 FDA UDI888.3390 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: Press-fit hip femur prosthesis, one-piece
AMIStem-P by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Press-fit hip femur prosthesis, one-piece.
- Paragon — GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED · Class II
- Klassic Blade Femoral Stem, Porous, Size 1 — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- Trivicta — ORTHO DEVELOPMENT CORP. · Class II
- RECLAIMTM — DEPUY (IRELAND) · Class II
- Novosource Total Hip System — Novosource, Inc. · Class II
- PROFEMUR® — MicroPort Orthopedics Inc. · Class II
- NEXUS — MicroPort Orthopedics Inc. · Class II
- Trivicta — ORTHO DEVELOPMENT CORP. · Class II
Cleared under the same submission
K173794 also covers:
- AMIStem-H Proximal Coating — Medacta International
- AMIStem-H Proximal Coating — Medacta International
- AMIStem-H Proximal Coating — Medacta International
- AMIStem-P — Medacta International
- AMIStem-P — Medacta International
- AMIStem-P — Medacta International
- AMIStem-P — Medacta International
- AMIStem-P — Medacta International
- AMIStem-P — Medacta International
- AMIStem-P — Medacta International
- AMIStem-P — Medacta International
- AMIStem-P — 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 f2ee1303-037f-400f-a4a7-14e220476b6d 34 fields · synced May 30, 2026