STALIF C; STALIF C-Ti— 510(k) K150053
Substantially EquivalentCentinel Spine, Inc.
FDA 510(k) clearance K150053 for STALIF C; STALIF C-Ti, Substantially Equivalent on 2015-06-24. Applicant: Centinel Spine, Inc.. Device class: 2.
Clearance details
- Applicant
- Centinel Spine, Inc.
- Product code
- Code OVE
- Device class
- Class 2
- Regulation
- 21 CFR 888.3080
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
Recent devices under product code OVE
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
- K150643 — Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti
- K141942 — MIDLINE II TI
- K142079 — STALIF CTI, STALIF C
Adverse events under product code OVE
product code OVE- Injury
- 293
- Malfunction
- 710
- Total
- 1,003
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.