Identity
- Trade Name
- OR3O Dual Mobility FDA UDI
- Generic Name
- Acetabulum prosthesis trial, prefabricated, reusable FDA UDI
- Device Name
- OR3O DUAL MOBILITY TRIAL LINER 44/58 FDA UDI
- Model / Reference
- 71353306 FDA UDI
- Description
- OR3O DUAL MOBILITY TRIAL LINER 44/58 FDA UDI
Identifiers
- Catalog Number
- 71353306 FDA UDI
- Primary DI / UDI-DI
- 00885556710494 FDA UDI
- 510(k) Number
- K191002 FDA UDI
- FDA Product Code
- LPH FDA UDI
- GMDN Term
- Acetabulum prosthesis trial, prefabricated, reusable 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
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: Acetabulum prosthesis trial, prefabricated, reusable
OR3O Dual Mobility by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetabulum prosthesis trial, prefabricated, reusable.
- Trabecular Metal® — Zimmer, Inc. · Class I
- G7 PROVISIONAL SHELL — Biomet Orthopedics, Inc. · Class II
- Bipolar Head — Limacorporate · Class II
- Acetabular Cups — Limacorporate · Class II
- Novation — Exactech, Inc. · Class I
- TRIAL NECK for Exacta S Rasp - Mark S - Standard — Permedica S.p.A · Class IIa
- INSTRUMENT — Howmedica Osteonics Corp. · Class II
- MultiPolar® — Zimmer, Inc. · Class I
Cleared under the same submission
K191002 also covers:
- OR3O Dual Mobility — Smith & Nephew, Inc.
- OR3O Dual Mobility — Smith & Nephew, Inc.
- OR3O Dual Mobility — Smith & Nephew, Inc.
- OR3O Dual Mobility — Smith & Nephew, Inc.
- OR3O Dual Mobility — Smith & Nephew, Inc.
- OR3O Dual Mobility — Smith & Nephew, Inc.
- OR3O Dual Mobility — Smith & Nephew, Inc.
- OR3O Dual Mobility — Smith & Nephew, Inc.
- OR3O Dual Mobility — Smith & Nephew, Inc.
- OR3O Dual Mobility — Smith & Nephew, Inc.
- OR3O Dual Mobility — Smith & Nephew, Inc.
- OR3O Dual Mobility — Smith & Nephew, Inc.
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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 05ce69d5-60e9-4880-83e4-6b648b10641a 36 fields · synced Jun 8, 2026