Identity
- Trade Name
- Corin Bipolar Prosthesis FDA UDI
- Generic Name
- Bipolar femoral head outer component, hemiarthroplasty FDA UDI
- Device Name
- 26mm Bipolar Semi Assembled FDA UDI
- Model / Reference
- 111.959 FDA UDI
- Description
- 26mm Bipolar Semi Assembled FDA UDI
Identifiers
- Catalog Number
- 111.959 FDA UDI
- Primary DI / UDI-DI
- 05055196979512 FDA UDI
- 510(k) Number
- K925897 FDA UDI
- FDA Product Code
- KWY FDA UDI
- GMDN Term
- Bipolar femoral head outer component, hemiarthroplasty FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3390 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
Radiation Sterilization FDA UDI
Category: Bipolar femoral head outer component, hemiarthroplasty
Corin Bipolar Prosthesis by Corin Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bipolar femoral head outer component, hemiarthroplasty.
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- UHR — Howmedica Osteonics Corp. · Class II
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Cleared under the same submission
K925897 also covers:
- Corin Bipolar Prosthesis — CORIN LTD
- Corin Bipolar Prosthesis — CORIN LTD
- Corin Bipolar Prosthesis — CORIN LTD
- Corin Bipolar Prosthesis — CORIN LTD
- Corin Bipolar Prosthesis — CORIN LTD
- Corin Bipolar Prosthesis — CORIN LTD
- Corin Bipolar Prosthesis — CORIN LTD
- Corin Bipolar Prosthesis — CORIN LTD
- Corin Bipolar Prosthesis — CORIN LTD
- Corin Bipolar Prosthesis — CORIN LTD
- Corin Bipolar Prosthesis — CORIN LTD
- Corin Bipolar Prosthesis — CORIN LTD
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
- Corin Ltd
Sources (1)
- FDA UDI a3e6600f-9d99-4310-8087-10a41d75ed98 36 fields · synced May 30, 2026