FDA 510(k), K053536, DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

FDA 510(k), K053536, DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS

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510(K) Number: K053536
Device Name: DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS
Manufacturer:
Device Classification Name: Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Regulation Number: 888.3330
Classification Product Code: KWA
Date Received: 12/19/2005
Decision Date: 03/16/2006
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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