Identity
- Trade Name
- Metafix Hip Stem FDA UDI
- Generic Name
- Femoral stem prosthesis trial FDA UDI
- Device Name
- 135˚ Short Neck Trial FDA UDI
- Model / Reference
- 340.473 FDA UDI
- Description
- 135˚ Short Neck Trial FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055343894026 FDA UDI
- 510(k) Number
- K153381 FDA UDI
- FDA Product Code
- MEH FDA UDIOQI FDA UDIJDI FDA UDIKWY FDA UDIKWL FDA UDILZO FDA UDI
- GMDN Term
- Femoral stem prosthesis trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3350 FDA UDI888.3390 FDA UDI888.3360 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Femoral stem prosthesis trial
Metafix Hip Stem by Corin Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Femoral stem prosthesis trial.
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Cleared under the same submission
K153381 also covers:
- Metafix HIp Stem — CORIN LTD
- Metafix HIp Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — CORIN LTD
- Metafix Hip Stem — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Corin Ltd
Sources (1)
- FDA UDI 56b4050a-7af6-4a7f-955f-7367993659d1 34 fields · synced May 30, 2026