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Summit Spine

FDA Regulatory Profile

Summit Spine has 0 FDA recalls, 1 inspection, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Oct 10, 2018 · NAI
Latest 510(k)
Jun 20, 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) clearances2Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 10, 2018Georgetown, TXDevicesNo Action Indicated (NAI)3011145476

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
K163494Summit Spine Channel Cervical Interbody Fusion SystemJun 20, 2017
K170572Summit Spine Yellowstone Lumbar Interbody Fusion SystemApr 26, 2017

FDA data resources