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

Devices

BrandModelCompanyProduct codesPrimary DI
ShurFit Interbody Device26-221015-15PRECISION SPINE, INC.KWQ MAX00840019910897
ShurFit Interbody Device38-2907PRECISION SPINE, INC.KWQ MAX00840019910453
ShurFit Interbody Device26-221010-10PRECISION SPINE, INC.KWQ MAX00840019910378
ShurFit Interbody DeviceTLIF24-09PPRECISION SPINE, INC.KWQ MAX00840019909822
ShurFit® LLIF System23-EC2245-16PRECISION SPINE, INC.KWQ MAX00840019906388
ShurFit Interbody SystemALIF30-11PRECISION SPINE, INC.KWQ MAX00840019942805
MD Vue Discectomy60-SC-5002PRECISION SPINE, INC.KWQ MAX00840019918886
ShurFit Interbody Device26-220815-11PRECISION SPINE, INC.KWQ MAX00840019911535
ShurFit Interbody Device44-3015-14PRECISION SPINE, INC.KWQ MAX00840019910743
ShurFit® LLIF System23-LC1860-12PRECISION SPINE, INC.MAX00840019966481
ShurFit Interbody SystemALIF36-17PRECISION SPINE, INC.KWQ MAX00840019942898
ShurFit Interbody Device26-250810-16PRECISION SPINE, INC.KWQ MAX00840019911856
ShurFit® LLIF System23-PC1850-16PRECISION SPINE, INC.KWQ MAX00840019906630
ShurFit® LLIF System23-EC1845-14PRECISION SPINE, INC.KWQ MAX00840019906173
ShurFit® LLIF System23-LC2245-12PRECISION SPINE, INC.MAX00840019966535
ShurFit® LLIF System23-LC1850-14PRECISION SPINE, INC.MAX00840019966399
AccuFit RP SystemRPIF13PRECISION SPINE, INC.KWQ MAX00840019912365
ShurFit Interbody Device26-251005-12PRECISION SPINE, INC.KWQ MAX00840019911054
ShurFit Interbody DeviceALIF0826-11PPRECISION SPINE, INC.KWQ MAX00840019911948
ShurFit Interbody DevicePLIF22-16PPRECISION SPINE, INC.KWQ MAX00840019909693
ShurFit® LLIF System23-PC2445-12PRECISION SPINE, INC.MAX00840019966146
ShurFit® LLIF System23-EC2460-14PRECISION SPINE, INC.MAX00840019966108
ShurFit Interbody Device26-220805-11PRECISION SPINE, INC.KWQ MAX00840019911382
ShurFit® LLIF System23-EC2255-16PRECISION SPINE, INC.KWQ MAX00840019906487
ShurFit® LLIF System23-LC2445-14PRECISION SPINE, INC.MAX00840019966740