FDA 510(k), K140300, COLLAGEN TENDON SHEET-DDI (CTS-DDI)

FDA 510(k), K140300, COLLAGEN TENDON SHEET-DDI (CTS-DDI)

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510(K) Number: K140300
Device Name: COLLAGEN TENDON SHEET-DDI (CTS-DDI)
Manufacturer: ROTATION MEDICAL, INC.
Device Classification Name: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
Regulation Number: 878.3300
Classification Product Code: OWY
Date Received: 02/06/2014
Decision Date: 03/26/2014
Regulation Medical Specialty: General & Plastic Surgery

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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