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FDA 510(k)

HEMISPHERE CEMENTED CUP

K-Number: K971581 · 1997-07-18

ApplicantOrtho Development Corp.
Decision Date1997-07-18
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEMISPHERE CEMENTED 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 1997-07-18 under 510(k) number K971581. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMISPHERE CEMENTED CUP?

HEMISPHERE CEMENTED CUP is a medical device that received FDA 510(k) clearance on 1997-07-18. The listed applicant is Ortho Development Corp.. The 510(k) number is K971581.

When did HEMISPHERE CEMENTED CUP receive FDA 510(k) clearance?

HEMISPHERE CEMENTED CUP received FDA 510(k) clearance on 1997-07-18, under 510(k) number K971581.

Who is the listed applicant for HEMISPHERE CEMENTED 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 HEMISPHERE CEMENTED CUP?

The FDA product code for HEMISPHERE CEMENTED CUP is JDI.

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Related Devices (Code: JDI)

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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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