Identity
- Trade Name
- Initia Total Hip System FDA UDI
- Generic Name
- Metal-on-polyethylene total hip prosthesis FDA UDI
- Device Name
- STDHO LINER 26-50 FDA UDI
- Model / Reference
- GMH02-200059 FDA UDI
- Description
- STDHO LINER 26-50 FDA UDI
Identifiers
- Catalog Number
- GMH02-200059 FDA UDI
- Primary DI / UDI-DI
- 04547898307102 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Metal-on-polyethylene total hip 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Metal-on-polyethylene total hip prosthesis
Initia Total Hip System by Kyocera Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Kyocera Corporation
Sources (1)
- FDA UDI c9c56f63-1bbd-4462-85f4-c740d3f053f8 36 fields · synced Jun 8, 2026