FDA 510(k), K132250, INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM

FDA 510(k), K132250, INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM

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510(K) Number: K132250
Device Name: INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
Manufacturer: INTEGRA LIFE SCIENCES CORPORATION
Device Classification Name: Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Regulation Number: 888.3800
Classification Product Code: JWJ
Date Received: 07/19/2013
Decision Date: 03/24/2014
Regulation Medical Specialty: Orthopedic

Total Pages: 904
Fully Redacted Pages: 745
Content Pages: 159

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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