FDA 510(k), K182848, ROSA ONE Spine application
FDA 510(k), K182848, ROSA ONE Spine application
510(K) Number: K182848
Device Name: ROSA ONE Spine application
Manufacturer: Serge Tabet
Device Classification Name: Orthopedic Stereotaxic Instrument
Regulation Number: OLO
Classification Product Code: KXA
Date Received: 10/09/2018
Decision Date: 03/22/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Total pages: 3265
Fully redacted pages: 3115
Content pages: 150
Couldn't load pickup availability
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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