FDA 510(k), K210099, Meticuly Patient-Specific Titanium Mesh Implant

510(K) Number: K210099
Device Name: Meticuly Patient-Specific Titanium Mesh Implant
Manufacturer: Peeranoot Lohwongwatana
Device Classification Name: Plate, Cranioplasty, Preformed, Non-Alterable
Regulation Number: GXN
Classification Product Code: KXA
Date Received: 01/14/2021
Decision Date: 12/21/2021
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology

335 pages (1,760 of 2.095 original pages are fully redacted)