DeviceClearance

CHESAPEAKE (CERVICAL COMPONENTS)— 510(k) K111439

Substantially Equivalent

K2m, Inc.

FDA 510(k) clearance K111439 for CHESAPEAKE (CERVICAL COMPONENTS), Substantially Equivalent on 2011-08-24. Applicant: K2m, Inc.. Device class: 2.

Clearance details

Applicant
K2m, 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
Leesburg, VA, US
Download summary PDFView on FDA.gov ↗

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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 →

Recalls naming K111439

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111439.

Data sourced from openFDA. This site is unofficial and independent of the FDA.