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Facilis™ Spinal System — Baui Biotech Co., Ltd. (510(k) K161231)

Facilis™ Spinal System — Baui Biotech Co., Ltd. (510(k) K161231) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Facilis™ Spinal System; Applicant: Baui Biotech Co., Ltd.; Clearance track: 510(k).

Device nameFacilis™ Spinal System
ApplicantBaui Biotech Co., Ltd.
Clearance track510(k)
Submission numberK161231
DecisionSubstantially Equivalent
Decision date2017-01-23
Date received2016-05-02
Product codeNKB
Device class2
Medical specialtyOrthopedic
Applicant locationTW
SourceopenFDA device

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