Centinel Spine, Inc.
Centinel Spine, Inc. holds FDA 510(k) medical device clearances, first cleared 2012, most recent 2018, with 6 FDA device recalls on record.
Top product codes for Centinel Spine, Inc.
FDA recalls by Centinel Spine, Inc.
- Z-2050-2026 — Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
- Z-2051-2026 — Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
- Z-1426-2026 — Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
- Z-3212-2024 — prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog Number: PDSM5
- Z-3213-2024 — prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
- Z-1406-2021 — Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD), Part number: 09.820.055S
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Centinel Spine, Inc.
- K173347 — STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX
- K152211 — PCT System
- K150053 — STALIF C; STALIF C-Ti
- K150643 — Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti
- K141942 — MIDLINE II TI
- K142079 — STALIF CTI, STALIF C
- K133200 — STALIF C(R)
- K133286 — MIDLINE (TM)
- K130461 — STALIF X
- K120819 — STALIF C
Data sourced from openFDA. This site is unofficial and independent of the FDA.