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Centinel Spine, Inc.

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
14
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1426-2026Class IIBrand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A December 31, 2025
Z-3212-2024Class IIprodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5July 18, 2024
Z-3213-2024Class IIprodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5July 18, 2024
Z-1406-2021Class IIProdisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patientsMarch 5, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K250554prodisc® L InstrumentsApril 25, 2025
K242869prodisc® L InstrumentsDecember 17, 2024
K221848prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsAugust 19, 2022
K173347STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLMay 8, 2018
K152211PCT SystemDecember 1, 2015
K150053STALIF C; STALIF C-TiJune 24, 2015
K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-TiJune 8, 2015
K141942MIDLINE II TINovember 7, 2014
K142079STALIF CTI, STALIF COctober 24, 2014
K133200STALIF C(R)May 8, 2014
K133286MIDLINE (TM)January 9, 2014
K130461STALIF XAugust 28, 2013
K120819STALIF CAugust 31, 2012
K101301STALIF MIDLINESeptember 24, 2010