Identity
- Trade Name
- AML FDA UDI
- Generic Name
- Coated femoral stem prosthesis, one-piece FDA UDI
- Device Name
- AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 18.0mm SMALL STATURE 150mm LENGTH 43mm OFFSET FDA UDI
- Model / Reference
- 1554-01-180 FDA UDI
- Description
- AML HIP SYSTEM FEMORAL STEM 12/14 TAPER 18.0mm SMALL STATURE 150mm LENGTH 43mm OFFSET FDA UDI
Identifiers
- Catalog Number
- 155401180 FDA UDI
- Primary DI / UDI-DI
- 10603295058274 FDA UDI
- 510(k) Number
- K012364 FDA UDI
- FDA Product Code
- JDI FDA UDILPH FDA UDI
- GMDN Term
- Coated femoral stem prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3358 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: Coated femoral stem prosthesis, one-piece
Aml by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Coated femoral stem prosthesis, one-piece.
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Cleared under the same submission
K012364 also covers:
- AML — DEPUY ORTHOPAEDICS, INC.
- AML — DEPUY ORTHOPAEDICS, INC.
- AML — DEPUY ORTHOPAEDICS, INC.
- AML — DEPUY ORTHOPAEDICS, INC.
- AML — DEPUY ORTHOPAEDICS, INC.
- AML — DEPUY ORTHOPAEDICS, INC.
- AML — DEPUY ORTHOPAEDICS, INC.
- AML — DEPUY ORTHOPAEDICS, INC.
- AML — DEPUY ORTHOPAEDICS, INC.
- AML — DEPUY ORTHOPAEDICS, INC.
- AML — DEPUY ORTHOPAEDICS, INC.
- AML — DEPUY ORTHOPAEDICS, INC.
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
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI 9d99b93a-6819-4975-9269-4117cf6b8f63 36 fields · synced Jun 8, 2026