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FDA 510(k) K150621, OsteoSelect PLUS Demineralized Bone Matrix Putty, by Bacterin International, Inc.

FDA 510(k) K150621, OsteoSelect PLUS Demineralized Bone Matrix Putty, by Bacterin International, Inc.

$89.00 USD
$89.00 USD
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510(K) Number: K150621
Device Name: OsteoSelect PLUS Demineralized Bone Matrix Putty
Manufacturer: Bacterin International, Inc.
Device Classification Name: Filler, Bone Void, Calcium Compound
Regulation Number: MQV
Classification Product Code: KXA
Date Received: 03/11/2015
Decision Date: 08/18/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic

  • Total PDF Pages: 356
  • Fully Redacted Pages: 146
  • Usable Pages: 210

Sections Included

  • Administrative / Introductory Materials: pages 1-51; 70.6% redacted (Heavy Redaction)
  • Indications for Use: pages 52-64; 0.0% redacted (Unredacted)
  • Labeling: pages 65-167; 61.2% redacted (Heavy Redaction)
  • Indications for Use: pages 168-326; 29.6% redacted (Moderate Redaction)
  • Clinical Testing: pages 327-355; 0.0% redacted (Unredacted)
  • Indications for Use: pages 356; 0.0% redacted (Unredacted)

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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