ClearanceBrief
510(k) K001044 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation

ACME SPINE SYSTEM - SERIES 6000, 7000, MONOAXIAL AND POLYAXIAL SCREW SYSTEM

ApplicantAcme Spine, LLC, Riverside CA, US
DecisionSubstantially Equivalent for Some Indications, Nov 3, 2000
ReceivedMar 31, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K001044

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.