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FDA 510(k)

BI-LOC BIPOLAR CUP

K-Number: K961793 · 1996-07-26

ApplicantOrtho Development Corp.
Decision Date1996-07-26
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BI-LOC 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 1996-07-26 under 510(k) number K961793. 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 BI-LOC BIPOLAR CUP?

BI-LOC BIPOLAR CUP is a medical device that received FDA 510(k) clearance on 1996-07-26. The listed applicant is Ortho Development Corp.. The 510(k) number is K961793.

When did BI-LOC BIPOLAR CUP receive FDA 510(k) clearance?

BI-LOC BIPOLAR CUP received FDA 510(k) clearance on 1996-07-26, under 510(k) number K961793.

Who is the listed applicant for BI-LOC 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 BI-LOC BIPOLAR CUP?

The FDA product code for BI-LOC BIPOLAR CUP is KWY.

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Other records listing Ortho Development Corp. as applicant

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Related Devices (Code: 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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