FDA 510(k) K210136, PhantomMSK Hip, by OrthoGrid Systems, Inc.

FDA 510(k) K210136, PhantomMSK Hip, by OrthoGrid Systems, Inc.

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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

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