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Elite Surgical Supplies (Pty), Ltd.

FDA Regulatory Profile

Elite Surgical Supplies (Pty), Ltd. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 24, 2017 · VAI
Latest 510(k)
Apr 30, 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) clearances4Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 24, 2017Pretoria, South AfricaDevicesVoluntary Action Indicated (VAI)3005325790

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
K200523Biolign® Roto-Loc Cervical Plate SystemApr 30, 2020
K130274BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEMOct 29, 2013
K080075MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEMJan 28, 2008
K063453VERTEFIX PEDICLE SCREW SPINAL SYSTEMAug 30, 2007

FDA data resources