Gpc Medical, Ltd.

FDA Regulatory Profile

Gpc Medical, Ltd. has 0 FDA recalls, 2 inspections, 6 510(k) clearances and 1 compliance action on record.

Latest inspection
Oct 24, 2019 · OAI
Latest 510(k)
Feb 10, 2022

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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) clearances6Oct 4, 2026Not statedCurrent
Inspections2Oct 26, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Oct 24, 2019Loni, IndiaDevicesOfficial Action Indicated (OAI)3006513362
Mar 3, 2011Loni, IndiaDevicesVoluntary Action Indicated (VAI)3006513362

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
K203811GPC Intraheal Intramedullary Nailing SystemFeb 10, 2022
K210198GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm…Jan 7, 2022
K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemMar 31, 2017
K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.May 17, 2016
K143245GPC Intramedullary Nailing SystemsSep 30, 2015
K092493GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEMMar 29, 2010