FDA 510(k), K052917, STRYKER COMPARTMENTAL KNEE SYSTEM

FDA 510(k), K052917, STRYKER COMPARTMENTAL KNEE SYSTEM

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510(K) Number: K052917
Device Name: STRYKER COMPARTMENTAL KNEE SYSTEM
Manufacturer:
Device Classification Name: Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Regulation Number: 888.3560
Classification Product Code: NPJ
Date Received: 10/17/2005
Decision Date: 12/27/2005
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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