Tritanium C Anterior Cervical Cage— 510(k) K171496

Substantially Equivalent

Stryker Spine

FDA 510(k) clearance K171496 for Tritanium C Anterior Cervical Cage, Substantially Equivalent on 2017-09-06. Applicant: Stryker Spine. Device class: 2.

Clearance details

Applicant
Stryker Spine
Product code
Product code ODP
Device class
Class 2
Regulation
21 CFR 888.3080
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Allendale, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code ODP

product code ODP
Injury
310
Total
310

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.