Bonafix Surgical And Dental Implants, LLC

FDA Regulatory Profile

Bonafix Surgical And Dental Implants, LLC has 0 FDA recalls, 2 inspections, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 11, 2019 · NAI
Latest 510(k)
Jul 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) clearances3Oct 4, 2026Not statedCurrent
Inspections2Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 11, 2019Delray Beach, FLDevicesNo Action Indicated (NAI)3009829584
Feb 27, 2015Delray Beach, FLDevicesVoluntary Action Indicated (VAI)3009829584

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
K162853Bonafix TWO - Dental Implant SystemJul 14, 2017
K122052MINIFIX BALL MINIFIX ONENov 28, 2012
K113650ORTHOFIX SCREWOct 3, 2012