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Trans1 Incorporated

FDA Regulatory Profile

Trans1 Incorporated has 0 FDA recalls, 3 inspections, 14 510(k) clearances and 0 compliance actions on record.

Latest inspection
Jun 12, 2017 · VAI
Latest 510(k)
Nov 20, 2019

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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) clearances14Oct 4, 2026Not statedCurrent
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 12, 2017Wilmington, NCDevicesVoluntary Action Indicated (VAI)3011302058
Sep 11, 2013Wilmington, NCDevicesNo Action Indicated (NAI)3011302058
May 26, 2010Wilmington, NCDevicesNo Action Indicated (NAI)3011302058

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
K192792TranS1 AxiaLIF Plus SystemNov 20, 2019
K191791TranS1 Interbody Fusion SystemSep 25, 2019
K123997TRANS1LATERAL INTERBODY FUSION SYSTEMApr 1, 2013
K120991TRANS1 INTERBODY FUSION SYSTEMAug 23, 2012
K102334TRANS1 AXIALIF PLUSMar 14, 2011
K100210TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, TAug 26, 2010
K092124AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF IIJan 21, 2010
K073643TRANS1 AXIALIF 2-LEVEL OR II SYSTEMApr 28, 2008
K073515TRANS1 FACET SCREWMar 11, 2008
K073514TRANS1 AXIAL FIXATON SYSTEMJan 11, 2008
K051856TRANS1 FACET SCREWSSep 26, 2005
K050965TRANS1 AXIALIF SYSTEMJun 14, 2005
K040426TRANS1 AXIAL FIXATION SYSTEMDec 17, 2004
K032891TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KITJan 15, 2004

FDA data resources