Identity
- Trade Name
- SOLUTION SYSTEM FDA UDI
- Generic Name
- Coated femoral stem prosthesis, one-piece FDA UDI
- Device Name
- SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER HIP STEM W/ POROCOAT 8 Inches 13.5mm STD FDA UDI
- Model / Reference
- 1571-14-000 FDA UDI
- Description
- SOLUTION REVISION HIP SYSTEM FEMORAL STEM 12/14 TAPER HIP STEM W/ POROCOAT 8 Inches 13.5mm STD FDA UDI
Identifiers
- Catalog Number
- 157114000 FDA UDI
- Primary DI / UDI-DI
- 10603295060758 FDA UDI
- 510(k) Number
- K953703 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Coated femoral stem prosthesis, one-piece 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: Coated femoral stem prosthesis, one-piece
Solution System by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated femoral stem prosthesis, one-piece.
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- EMPHASYS — DEPUY (IRELAND) · Class II
- ACTIS — DEPUY (IRELAND) · Class II
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- EMPHASYS — DEPUY (IRELAND) · Class II
- ACTIS — DEPUY (IRELAND) · Class II
Cleared under the same submission
K953703 also covers:
- SOLUTION SYSTEM — DEPUY ORTHOPAEDICS, INC.
- SOLUTION SYSTEM — DEPUY ORTHOPAEDICS, INC.
- SOLUTION SYSTEM — DEPUY ORTHOPAEDICS, INC.
- SOLUTION SYSTEM — DEPUY ORTHOPAEDICS, INC.
- SOLUTION SYSTEM — DEPUY ORTHOPAEDICS, INC.
- SOLUTION SYSTEM — DEPUY ORTHOPAEDICS, INC.
- SOLUTION SYSTEM — DEPUY ORTHOPAEDICS, INC.
- SOLUTION SYSTEM — DEPUY ORTHOPAEDICS, INC.
- SOLUTION SYSTEM — DEPUY ORTHOPAEDICS, INC.
- SOLUTION SYSTEM — DEPUY ORTHOPAEDICS, INC.
- SOLUTION SYSTEM — DEPUY ORTHOPAEDICS, INC.
- SOLUTION SYSTEM — 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 |
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Manufacturer
- Manufacturer
- Depuy Orthopaedics, Inc.
Sources (1)
- FDA UDI 78dd33f2-a59e-4f1d-87a9-9678ebc79085 36 fields · synced Jun 8, 2026