FDA 510(k), K961725, OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION

FDA 510(k), K961725, OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION

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510(K) Number: K961725
Device Name: OSCAR ORTHOSONICS SYSTEM FOR CEMENTED ARTHROPLASTY REVISION
Manufacturer:
Device Classification Name: Instrument, Surgical, Sonic And Accessory/Attachment
Regulation Number: 888.4580
Classification Product Code: JDX
Date Received: 05/03/1996
Decision Date: 08/01/1996
Regulation Medical Specialty: Orthopedic

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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