Flospine

FDA Regulatory Profile

Flospine has 0 FDA recalls, 4 inspections, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Feb 7, 2025 · VAI
Latest 510(k)
Feb 24, 2023

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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) clearances4Oct 4, 2026Not statedCurrent
Inspections4Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Feb 7, 2025Boca Raton, FLDevicesVoluntary Action Indicated (VAI)3011513267
Nov 18, 2022Boca Raton, FLDevicesVoluntary Action Indicated (VAI)3011513267
Dec 13, 2019Boca Raton, FLDevicesNo Action Indicated (NAI)3011513267
Sep 29, 2016Boca Raton, FLDevicesVoluntary Action Indicated (VAI)3011513267

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
K223231Ti-Largo Cervical Interbody SystemFeb 24, 2023
K210182PANAMA™ Anterior Cervical Plate (ACP) SystemApr 7, 2021
K193255Largo PEEK Interbody SystemFeb 20, 2020
K141850FLOSPINE PEDICLE SCREW SYSTEMOct 27, 2014