ClearanceBrief
510(k) K964544 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation

OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY

ApplicantOsteonics Corp., Allendale NJ, US
DecisionSubstantially Equivalent, Feb 11, 1997
ReceivedNov 13, 1996
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K964544

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.