CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM

Screw, Fixation, Bone

ORTHOPEDIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Cancellous Screw Long Thread Diameter 6.5mm.

Pre-market Notification Details

Device IDK895219
510k NumberK895219
Device Name:CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM
ClassificationScrew, Fixation, Bone
Applicant ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward,  CA  94545
ContactRobert R Moore
CorrespondentRobert R Moore
ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward,  CA  94545
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-08-18
Decision Date1989-09-12

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