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MVA

Orthosis, Cranial

Product code
MVA
Device name
Orthosis, Cranial
Device class
Class 2
21 CFR
21 CFR 882.5970
Medical specialty
Neurology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
43 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-08-30.

NumberDecision dateApplicantDevice nameSummary
K2419572024-08-30Invent Medical USA, LLCTalee, Talee PostOpPDF

1 summaries are archived here for direct download.

Official FDA classification page: MVA
Classification and pathway per current FDA publications. Data from openFDA (CC0).