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Pinnacle Spine Group, LLC

FDA Regulatory Profile

Pinnacle Spine Group, LLC has 0 FDA recalls, 1 inspection, 13 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 13, 2013 · VAI
Latest 510(k)
Dec 14, 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) clearances13Oct 4, 2026Not statedCurrent
Inspections1Oct 23, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 13, 2013Dallas, TXBiologicsVoluntary Action Indicated (VAI)3008545348

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
K172349InFill® Interbody Fusion DeviceDec 14, 2017
K152259InFill Interbody Fusion DeviceNov 19, 2015
K151184InFill Interbody Fusion DevicesJul 14, 2015
K150206InFill Interbody Fusion DevicesApr 3, 2015
K143488InFill Graft Delivery SystemDec 17, 2014
K141282PGS 5.5 MM CANNULATED PEDICLE SCREWDec 2, 2014
K140066INFILL CERVICALMay 5, 2014
K133721INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE…Mar 31, 2014
K124012INFILL OBLIQUE TLIF DEVICEJun 4, 2013
K121476INFILL GRAFT DELIVERY SYSTEMAug 29, 2012
K121733INFILL INTERVERTEBRAL BODY FUSION DEVICEJul 13, 2012
K111632INFILL GRAFT DELIVERY SYSTEMAug 11, 2011
K103729INFILL INTERVERTEBRAL BODY FUSION DEVICEApr 18, 2011

FDA data resources