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Odc B2 Bipolar Cup

FDA 510(k)

Class II (US FDA 510(k))

510(k) K982389

by Ortho Development Corp.

Identifiers

510(k) Number
K982389 FDA 510(k)
FDA Product Code
KWY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3390 FDA 510(k)
Regulation Number
888.3390 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Odc B2 Bipolar Cup is a prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented, which is a type of orthopedic device. It is used in orthopedic applications, specifically for hip procedures. The device is classified under the product code KWY. The Odc B2 Bipolar Cup is a medical device designed to be used in orthopedic procedures.

The Odc B2 Bipolar Cup is supplied by Ortho Development Corp. and has been authorized with FDA 510K clearance, with the decision description being substantially equivalent. The device has a specific regulation, 888.3390, and is classified as a prosthesis. It is available with the product code KWY and the k number K982389. The device is intended for use in orthopedic settings.

Frequently asked questions

What is the ODC B2 Bipolar Cup used for?

The ODC B2 Bipolar Cup is used in orthopedic applications, specifically for hip procedures, as a type of prosthesis.

What type of clearance does the ODC B2 Bipolar Cup have?

The ODC B2 Bipolar Cup has FDA 510K clearance, with a decision description of substantially equivalent, under regulation 888.3390.

How is the ODC B2 Bipolar Cup supplied?

The ODC B2 Bipolar Cup is supplied by Ortho Development Corp.

What is the product code for the ODC B2 Bipolar Cup?

The product code for the ODC B2 Bipolar Cup is KWY, with the k number K982389.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ODC B2 BIPOLAR CUP (K982389) — FDA 510 (k) | Innolitics, ODC B2 Bipolar Cup - BEUDAMED, ODC B2 BIPOLAR CUP 510 (k) K982389 - FDA.report, Personalized Orthopedic Solutions for Knee & Hip | ODEV

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ortho Development Corp.

Sources (1)

  • FDA 510(k) K982389 24 fields · synced Oct 1, 2026