STORY FROM: Drugs & Medical Devices

Joint Stabilization Device Maker Not Required to Turn Over 510(k) Approval Documents, Kan. Federal Judge Says

WICHITA, Kan. — A Kansas federal judge has refused to make public certain documents the manufacturer of a joint preservation device submitted to the FDA during the 510(k) approval process, ruling that they constitute trade secrets and confidential commercial or financial information.

In a Sept. 18 order, Magistrate Judge Gwynne E. Birzer of the U.S. District Court for the District of Kansas said Orthopedic Sciences Inc. is not required to turn over the documents in a lawsuit accusing it of participating in a scheme to improperly bill patients and their insurers for medically unnecessary joint preservation surgeries that involved its ...

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