MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM— 510(k) K121569

Substantially Equivalent

Accel Spine

FDA 510(k) clearance K121569 for MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM, Substantially Equivalent on 2012-07-27. Applicant: Accel Spine.

Clearance details

Applicant
Accel Spine
Product code
Code ODP
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dallas, TX, US
Download summary PDFView on FDA.gov ↗

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.