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ISOBAR SPINAL SYSTEM — Scien'Tx USA, Inc. (510(k) K013440)

ISOBAR SPINAL SYSTEM — Scien'Tx USA, Inc. (510(k) K013440) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: ISOBAR SPINAL SYSTEM; Applicant: Scien'Tx USA, Inc.; Clearance track: 510(k).

Device nameISOBAR SPINAL SYSTEM
ApplicantScien'Tx USA, Inc.
Clearance track510(k)
Submission numberK013440
DecisionSubstantially Equivalent
Decision date2001-11-16
Date received2001-10-17
Product codeMNI
Device class2
Medical specialtyOrthopedic
Applicant locationTX, US
SourceopenFDA device

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