CAMBER SPINE COVERIS CERVICAL CAGE— 510(k) K133529

Substantially Equivalent

Camber Spine

FDA 510(k) clearance K133529 for CAMBER SPINE COVERIS CERVICAL CAGE, Substantially Equivalent on 2014-03-20. Applicant: Camber Spine. Device class: 2.

Clearance details

Applicant
Camber Spine
Product code
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
Newtown Square, PA, 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.