ClearanceBrief
510(k) K081011 ยท HWC Screw, Fixation, Bone

AREX SCRU 2 HEADLESS COMPRESSION SCREWS, MODELS: P2P10, P2P15, P2P20, P2P25, P2P30, P2P35, P2P40, P2P45

ApplicantArex USA, Collegeville PA, US
DecisionSubstantially Equivalent, Nov 7, 2008
ReceivedApr 9, 2008
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K081011

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.