Calvary Spine, LLC

FDA Regulatory Profile

Calvary Spine, LLC has 0 FDA recalls, 5 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 2, 2025 · NAI
Latest 510(k)
Nov 12, 2020

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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
Inspections5Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 2, 2025Towson, MDDevicesNo Action Indicated (NAI)3007279845
Jan 25, 2018Towson, MDDevicesVoluntary Action Indicated (VAI)3007279845
Jan 29, 2016Towson, MDDevicesNo Action Indicated (NAI)3007279845
Mar 21, 2013Towson, MDDevicesNo Action Indicated (NAI)3007279845
Mar 11, 2010Towson, MDDevicesNo Action Indicated (NAI)3007279845

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
K201568Calvary Spine Pedicle Screw SystemNov 12, 2020
K082260INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGESOct 17, 2008