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Neoortho Produtos Ortopedicos S/A

FDA Regulatory Profile

Neoortho Produtos Ortopedicos S/A has 0 FDA recalls, 1 inspection, 5 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 18, 2017 · NAI
Latest 510(k)
Jun 27, 2017

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances5Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 18, 2017Curitiba, BrazilDevicesNo Action Indicated (NAI)3009158523

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K162874Cannulated Screws NeoorthoJun 27, 2017
K141103INTRAMEDULLARY NAIL AND SCREWS-NEONAILSep 23, 2014
K132852PEEK CAGE FOR THE VERTEBRAL SPINEMay 29, 2014
K113733SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIXMar 23, 2012
K102641MINI AND MICRO FRAGMENTS RECONSTRUCTION SYSTEM-NEOFACEDec 20, 2010

FDA data resources