Ceterix Orthopaedics, Inc.

FDA Regulatory Profile

Ceterix Orthopaedics, Inc. has 0 FDA recalls, 1 inspection, 3 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 4, 2016 · NAI
Latest 510(k)
Aug 1, 2018

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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
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 4, 2016Fremont, CADevicesNo Action Indicated (NAI)3009131204

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
K181772NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)Aug 1, 2018
K180531NovoStitch Pro Meniscal Repair SystemMar 29, 2018
K143356NovoStitch Plus Meniscal Repair SystemJul 21, 2015