Identity
- Trade Name
- Omnifit FDA UDI
- Generic Name
- Polyethylene acetabulum prosthesis FDA UDI
- Device Name
- Acetabular Cup FDA UDI
- Model / Reference
- 61-3248 FDA UDI
- Description
- Acetabular Cup FDA UDI
Identifiers
- Catalog Number
- 61-3248 FDA UDI
- Primary DI / UDI-DI
- 07613327038491 FDA UDI
- 510(k) Number
- K803192 FDA UDI
- FDA Product Code
- KWZ FDA UDI
- GMDN Term
- Polyethylene acetabulum prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3310 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 — 32.0 Millimeter FDA UDIOuter Diameter — 48.0 Millimeter FDA UDI
Category: Polyethylene acetabulum prosthesis
Omnifit by Howmedica Osteonics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyethylene acetabulum prosthesis.
- ZCA® — Zimmer, Inc. · Class II
- Cenator Total Hip System — CORIN LTD · Class II
- ZCA® — Zimmer, Inc. · Class II
- REFLECTION — Smith & Nephew, Inc. · Class II
- ZCA® — Zimmer, Inc. · Class II
- ONVOY — GLOBUS MEDICAL, INC. · Class II
- Acetabular Cup — WALDEMAR LINK GmbH & Co. KG · Class II
- ZCA® — Zimmer, Inc. · Class II
Cleared under the same submission
K803192 also covers:
- Acetabular Cup — Howmedica Osteonics Corp.
- Acetabular Cup — Howmedica Osteonics Corp.
- Acetabular Cup — Howmedica Osteonics Corp.
- Acetabular Cup — Howmedica Osteonics Corp.
- Acetabular Cup — Howmedica Osteonics Corp.
- ODC — Howmedica Osteonics Corp.
- ODC — Howmedica Osteonics Corp.
- ODC — Howmedica Osteonics Corp.
- ODC — 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 21f21415-dd26-4208-9177-88a7194ff996 36 fields · synced May 30, 2026