FDA 510(k), K101451, APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD

FDA 510(k), K101451, APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD

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510(K) Number: K101451
Device Name: APEX MODULE HIP SYSTEM BIOLOX DELTA FEMORAL HEAD
Manufacturer:
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Regulation Number: 888.3353
Classification Product Code: LZO
Date Received: 05/25/2010
Decision Date: 06/22/2010
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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