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FDA 510(k)

ODC B2 BIPOLAR CUP

K-Number: K982389 · 1998-10-07

ApplicantOrtho Development Corp.
Decision Date1998-10-07
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ODC B2 BIPOLAR CUP is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corp.. It received FDA 510(k) clearance on 1998-10-07 under 510(k) number K982389. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ODC B2 BIPOLAR CUP?

ODC B2 BIPOLAR CUP is a medical device that received FDA 510(k) clearance on 1998-10-07. The listed applicant is Ortho Development Corp.. The 510(k) number is K982389.

When did ODC B2 BIPOLAR CUP receive FDA 510(k) clearance?

ODC B2 BIPOLAR CUP received FDA 510(k) clearance on 1998-10-07, under 510(k) number K982389.

Who is the listed applicant for ODC B2 BIPOLAR CUP?

The FDA 510(k) record lists Ortho Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ODC B2 BIPOLAR CUP?

The FDA product code for ODC B2 BIPOLAR CUP is KWY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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