Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti— 510(k) K150643

Name: FDA 510(k) clearance K150643
Creator: U.S. Food and Drug Administration
Published: 2015-06-08

Substantially Equivalent

Centinel Spine, Inc.

FDA 510(k) clearance K150643 for Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti, Substantially Equivalent on 2015-06-08. Applicant: Centinel Spine, Inc.. Device class: 2.

Clearance details

Applicant: Centinel Spine, Inc.
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2015-03-12
Decision date: 2015-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Centinel Spine, Inc.

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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 FLX2018-05-08
K152211 — PCT System2015-12-01
K150053 — STALIF C; STALIF C-Ti2015-06-24
K141942 — MIDLINE II TI2014-11-07
K142079 — STALIF CTI, STALIF C2014-10-24

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.