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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K111449

REVOLVE ADDITIONAL IMPLANTS · Globus Medical, Inc. · decided 2011-08-17 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
REVOLVE785.330GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044072556
REVOLVE585.341GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071597
REVOLVE585.152GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071252
REVOLVE185.855GLOBUS MEDICAL, INC.KWP MNH MNI NKB00889095049312
REVOLVE585.357GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071726
REVOLVE785.430GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044072648
REVOLVE585.166GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071368
REVOLVE585.342GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071603
REVOLVE585.247GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071443
REVOLVE785.890GLOBUS MEDICAL, INC.KWP MNH MNI NKB00889095181142
REVOLVE785.440GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044072655
REVOLVE585.351GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071665
REVOLVE785.880GLOBUS MEDICAL, INC.KWP MNH MNI NKB00889095181135
REVOLVE585.389GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071993
REVOLVE585.381GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071917
REVOLVE585.377GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071887
REVOLVE585.384GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071948
REVOLVE585.254GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071481
REVOLVE785.360GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044072570
REVOLVE585.386GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071962
REVOLVE585.367GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071795
REVOLVE585.362GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071740
REVOLVE585.246GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071436
REVOLVE785.420GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044072631
REVOLVE585.144GLOBUS MEDICAL, INC.KWP MNH MNI NKB00849044071207