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RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW — Xiamen Double Engline Medical Material Co., Ltd. (510(k) K112819)

RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW — Xiamen Double Engline Medical Material Co., Ltd. (510(k) K112819) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: RECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW; Applicant: Xiamen Double Engline Medical Material Co., L

Device nameRECONSTRUCTION LOCKING PLATE AND 3.5MM LOCKING SCREW
ApplicantXiamen Double Engline Medical Material Co., Ltd.
Clearance track510(k)
Submission numberK112819
DecisionSubstantially Equivalent
Decision date2011-12-16
Date received2011-09-28
Product codeHRS
Device class2
Medical specialtyOrthopedic
Applicant locationCN
SourceopenFDA device

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