Identity
- Trade Name
- Secur-Fit FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Device Name
- Cluster Acetabular Shell FDA UDI
- Model / Reference
- 2050-2054 FDA UDI
- Description
- Cluster Acetabular Shell FDA UDI
Identifiers
- Catalog Number
- 2050-2054 FDA UDI
- Primary DI / UDI-DI
- 07613327019957 FDA UDI
- 510(k) Number
- K943054 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Acetabular shell 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 54.0 Millimeter FDA UDI
Category: Acetabular shell
This comprehensive medical device is designed for orthopedic purposes, featuring a cluster acetabular shell that provides a stable and secure base for inner portion components. Manufactured from metal or polymer materials, this product is fixed to the pelvis using bone cement and/or fixation devices.
Similar devices
Also classified as Acetabular shell.
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- Klassic HD Acetabular Cup with Ti-Coat — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- POLARCUP — Smith & Nephew, Inc. · Class II
- 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
K943054 also covers:
- Omnifit — Howmedica Osteonics Corp.
- Omnifit — Howmedica Osteonics Corp.
- Omnifit — Howmedica Osteonics Corp.
- Omnifit — Howmedica Osteonics Corp.
- Omnifit — Howmedica Osteonics Corp.
- Omnifit — Howmedica Osteonics Corp.
- Omnifit — Howmedica Osteonics Corp.
- Omnifit — Howmedica Osteonics Corp.
- Omnifit — Howmedica Osteonics Corp.
- Omnifit — Howmedica Osteonics Corp.
- Omnifit — Howmedica Osteonics Corp.
- Omnifit — Howmedica Osteonics Corp.
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
- Howmedica Osteonics Corp.
Sources (1)
- FDA UDI 65dfa918-62f5-4b5f-a85f-0113eda51b78 36 fields · synced Jul 17, 2026