FDA 510(k), K142587, Vertical Expandable Prosthetic Titanium Rib

FDA 510(k), K142587, Vertical Expandable Prosthetic Titanium Rib

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510(K) Number: K142587
Device Name: Vertical Expandable Prosthetic Titanium Rib
Manufacturer: Depuy Synthes Spine, Inc.
Device Classification Name: prosthesis, rib replacement
Regulation Number: 888.3070
Classification Product Code: MDI
Date Received: 09/15/2014
Decision Date: 11/18/2014
Regulation Medical Specialty: Orthopedic

Total pages: 352
Fully redacted pages: 157
Content pages: 195

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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