MIDLINE II TI— 510(k) K141942
Substantially EquivalentCentinel Spine, Inc.
FDA 510(k) clearance K141942 for MIDLINE II TI, Substantially Equivalent on 2014-11-07. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
Recent devices under product code OVD
view allMore clearances from Centinel Spine, Inc.
view all- 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
- K142079 — STALIF CTI, STALIF C
Adverse events under product code OVD
product code OVD- Death
- 5
- Injury
- 495
- Total
- 500
Source: openFDA MAUDE database, through . 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.