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FDA 510(k), K210099, Meticuly Patient-Specific Titanium Mesh Implant
FDA 510(k), K210099, Meticuly Patient-Specific Titanium Mesh Implant
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$149.00 USD
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$149.00 USD
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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: 01/14/2021
Date Received: 12/21/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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: 01/14/2021
Date Received: 12/21/2021
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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