FDA 510(k), K123954, INFINITY TOTAL ANKLE SYSTEM

FDA 510(k), K123954, INFINITY TOTAL ANKLE SYSTEM

Regular price $415.84 USD
Regular price Sale price $415.84 USD
Sale Sold out

510(K) Number: K123954
Device Name: INFINITY TOTAL ANKLE SYSTEM
Manufacturer: WRIGHT MEDICAL TECHNOLOGY, INC.
Device Classification Name: prosthesis, ankle, semi-constrained, cemented, metal/polymer
Regulation Number: 888.3110
Classification Product Code: HSN
Date Received: 12/21/2012
Decision Date: 04/01/2013
Regulation Medical Specialty: Orthopedic

Total pages: 979  
Fully redacted pages: 828  
Content pages: 151  

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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