FDA 510(K) K153302 COFLEX-IF CLEARED 09/08/2016

FDA 510(K) K153302 COFLEX-IF CLEARED 09/08/2016

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Device Classification Name  Spinous Process Plate
510(k) Number  K153302
Device Name  coflex-IF
Applicant  PARADIGM SPINE, LLC
Regulation Number  888.3050
Classification Product Code  PEK 
Date Received  11/13/2015
Decision Date  09/08/2016
Decision  Substantially Equivalent (SESE)
Regulation Medical Specialty  Orthopedic
510k Review Panel  Orthopedic

Total pages: 1,102
Fully redacted pages: 821
Content pages: 281

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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