• FDA ABILIFY MAINTENA KIT NDA 202971 approval records — 41 FDA documents, 1,513 pages
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FDA 510(k) K180513, CustomizedBone Service, by Fin-Ceramica Faenza S.P.A.

FDA 510(k) K180513, CustomizedBone Service, by Fin-Ceramica Faenza S.P.A.

$857.04 USD
$857.04 USD
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FDA 510(k) records for CustomizedBone Service (K180513), submitted by Fin-Ceramica Faenza S.P.A..

  • 510(k) Number: K180513
  • Applicant: Fin-Ceramica Faenza S.P.A.
  • Decision Date: 05/15/2018
  • Decision: Substantially Equivalent (SESE)
  • Product Code: GXN GXN
  • Review Panel: Neurology
  • Total PDF Pages: 669
  • Fully Redacted Pages: 384
  • Usable Pages: 285

Sections Included

  • Administrative / Introductory Materials: pages 1-19; 78.9% redacted (Heavy Redaction)
  • Indications for Use: pages 20-38; 31.6% redacted (Moderate Redaction)
  • Device Description: pages 39-100; 54.8% redacted (Heavy Redaction)
  • Sterilization: pages 101-121; 57.1% redacted (Heavy Redaction)
  • Indications for Use: pages 122-128; 0.0% redacted (Unredacted)
  • Sterilization: pages 129-162; 2.9% redacted (Minimal Redaction)
  • Electrical Safety / EMC: pages 163-166; 0.0% redacted (Unredacted)
  • Device Description: pages 167-222; 19.6% redacted (Moderate Redaction)
  • Clinical Testing: pages 223-373; 84.1% redacted (Heavy Redaction)
  • Device Description: pages 374-669; 60.1% redacted (Heavy Redaction)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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