FDA 510(k) K210136, PhantomMSK Hip, by OrthoGrid Systems, Inc.
FDA 510(k) K210136, PhantomMSK Hip, by OrthoGrid Systems, Inc.
Device Classification Name: System, Image Processing, Radiological
510(k) Number: K210136
Device Name: PhantomMSK Hip
Applicant: OrthoGrid Systems, Inc.
Regulation Number: 892.205
Classification Product Code: LLZ
Date Received: 2021-01-19
Decision Date: 2021-02-18
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
510k Review Panel: Radiology
Total number of pages: 276
Fully redacted pages: 82
Content pages: 194
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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