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

Clearance record K162531

STERISPINE CC · Safe Orthopaedics · decided 2016-12-29 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
STERISPINE CCKITCCS09LSAFE ORTHOPAEDICSOVE03760219913146
STERISPINE CCKITCCS05LSAFE ORTHOPAEDICSOVE03760219913108
STERISPINE CCKITCCS06SSAFE ORTHOPAEDICSOVE03760219913078
STERISPINE CCKITCCS10LSAFE ORTHOPAEDICSOVE03760219913153
STERISPINE CCKITCCS08SSAFE ORTHOPAEDICSOVE03760219913092
STERISPINE CCKITCCANCSAFE ORTHOPAEDICSOVE03760219913054
STERISPINE CCKITCCS07SSAFE ORTHOPAEDICSOVE03760219913085
STERISPINE CCKITCCS08LSAFE ORTHOPAEDICSOVE03760219913139
STERISPINE CCKITCCS06LSAFE ORTHOPAEDICSOVE03760219913115
STERISPINE CCKITCCS05SSAFE ORTHOPAEDICSOVE03760219913061
STERISPINE CCKITCCS07LSAFE ORTHOPAEDICSOVE03760219913122