Identity
- Trade Name
- Trinity Acetabular Hip System FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Device Name
- Trinity Acetabular Shell Ø48mm Taper Size 2 FDA UDI
- Model / Reference
- 321.02.348 FDA UDI
- Description
- Trinity Acetabular Shell Ø48mm Taper Size 2 FDA UDI
Identifiers
- Catalog Number
- 321.02.348 FDA UDI
- Primary DI / UDI-DI
- 05055196927452 FDA UDI
- 510(k) Number
- K093472 FDA UDI
- FDA Product Code
- MEH FDA UDILZO FDA UDILWJ FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3360 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: Acetabular shell
Trinity Acetabular Hip System by Corin Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetabular shell.
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- ESOP® — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- ESOP® — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- REFLECTION — Smith & Nephew, Inc. · Class II
- Regenerex® Ringloc®+ Hip System — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K093472 also covers:
- Trinity Acetabular Hip System — CORIN LTD
- Trinity Acetabular Hip System — CORIN LTD
- Trinity Acetabular Hip System — CORIN LTD
- Trinity Acetabular Hip System — CORIN LTD
- Trinity Acetabular Hip System — CORIN LTD
- Trinity Acetabular Hip System — CORIN LTD
- Trinity Acetabular Hip System — CORIN LTD
- Trinity Acetabular Hip System — CORIN LTD
- Trinity Acetabular Hip System — CORIN LTD
- Trinity Acetabular Hip System — CORIN LTD
- Trinity Acetabular Hip System — CORIN LTD
- Trinity Acetabular Hip System — 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 681a6974-b2e2-49aa-9665-32fc36784660 36 fields · synced May 30, 2026