OREX (12X12 X-RAY DETECTABLE)

OREX (12X12 X-RAY DETECTABLE) is an FDA 510(k)-cleared medical device (K940767) manufactured by Thantex Specialties, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 18, 1994. Regulation: 8.