Identity
- Trade Name
- Omnifit FDA UDI
- Generic Name
- Constrained polyethylene acetabular liner FDA UDI
- Device Name
- 0degrees Series II Insert FDA UDI
- Model / Reference
- 2043C-2858 FDA UDI
- Description
- 0degrees Series II Insert FDA UDI
Identifiers
- Catalog Number
- 2043C-2858 FDA UDI
- Primary DI / UDI-DI
- 04546540037190 FDA UDI
- 510(k) Number
- K974685 FDA UDI
- FDA Product Code
- LWJ FDA UDILPH FDA UDIJDI FDA UDI
- GMDN Term
- Constrained polyethylene acetabular liner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3360 FDA UDI888.3358 FDA UDI888.3350 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
- Lumen/Inner Diameter — 28.0 Millimeter FDA UDI
Category: Constrained polyethylene acetabular liner
Omnifit by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Constrained polyethylene acetabular liner.
- Trilogy® — Zimmer, Inc. · Class II
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- G7® Freedom® Vivacit-E® — Zimmer, Inc. · Class II
- Active Articulation Hip System — Biomet Orthopedics, Inc. · Class II
- DURALOC — DEPUY ORTHOPAEDICS, INC. · Class II
- Novation — Exactech, Inc. · Class II
- CS2 Acet. Cup Sys. - VitalitE — SHALBY ADVANCED TECHNOLOGIES, INC. · Class III
- DELTA LINERS & ACCESSORIES — Limacorporate · Class II
Cleared under the same submission
K974685 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 |
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Manufacturer
- Manufacturer
- Howmedica Osteonics Corp.
Sources (1)
- FDA UDI 8e613d88-05d2-4bb9-825a-737c1f6debac 36 fields · synced May 30, 2026