FDA 510(k) K051656, OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM, by Osteobiologics, Inc.
FDA 510(k) K051656, OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM, by Osteobiologics, Inc.
Device Classification Name: Arthroscope
510(k) Number: K051656
Device Name: OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM
Applicant: Osteobiologics, Inc.
Regulation Number: 888.11
Classification Product Code: HRX
Date Received: 2005-06-21
Decision Date: 2005-10-25
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
510k Review Panel: Orthopedic
Total number of pages: 205
Fully redacted pages: 104
Content pages: 101
Couldn't load pickup availability
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.
View full details