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

Clearance record K150856

Reform Pedicle Screw System · Precision Spine, Inc. · decided 2015-07-07 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Reform Ti CT Modular MIS Pedicle Screw System64-BK-0201PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019942379
Reform TI Pedicle Screw System39-BK-0554PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019940658
Reform TI Pedicle Screw System39-SG-1000PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019940580
Reform Ti Modular39-SK-7570PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019933735
Reform TI Pedicle Screw System39-SB-6530PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019931922
Reform Ti Modular39-SK-7550PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019933704
Reform Ti Modular39-SK-6530PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019933599
Reform Pedicle Screw System39-MS-9512PRECISION SPINE, INC.KWP MNH MNI NKB OSH00815362028599
Reform Pedicle Screw System39-MS-4530PRECISION SPINE, INC.KWP MNH MNI NKB OSH00815362028162
Reform TI Pedicle Screw System39-SB-6540PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019931946
Reform TI Pedicle Screw System39-TR-1011PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019903035
Reform® Ti CT Modular MIS Pedicle Screw System64-BK-0124PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019967594
Reform Ti CT Modular MIS Pedicle Screw System64-SC-0114PRECISION SPINE, INC.NKB00840019942218
Reform Ti Modular39-SK-5045PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019933469
Reform TI Pedicle Screw System39-SG-8555PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019940313
Reform TI Pedicle Screw System39-SG-8550PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019940306
Reform Ti Modular39-SK-5550PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019933551
Reform Ti CT Modular MIS Pedicle Screw System64-BK-0111PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019942317
Reform TI Pedicle Screw System39-HM-1050PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019939881
Reform TI Pedicle Screw System39-HM-9555PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019939782
Reform TI Pedicle Screw System39-SB-6560PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019931984
Reform TI Pedicle Screw System39-SB-6550PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019931960
Reform TI Pedicle Screw System39-SG-4530PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019939980
Reform Ti Modular39-SC-0313PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019938679
Reform Ti Modular39-SC-0151PRECISION SPINE, INC.KWP MNH MNI NKB OSH00840019932547