DeviceClearance

ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM— 510(k) K130217

Substantially Equivalent

OrthoPediatrics Corp.

FDA 510(k) clearance K130217 for ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM, Substantially Equivalent on 2013-06-20. Applicant: OrthoPediatrics Corp.. Device class: 2.

Clearance details

Applicant
OrthoPediatrics Corp.
Product code
Code MBI
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Warsaw, IN, US
Download summary PDFView on FDA.gov ↗

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More clearances from OrthoPediatrics Corp.

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Adverse events under product code MBI

product code MBI
Injury
3,163
Malfunction
13,006
Other
2
Total
16,171

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 K130217

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 K130217.

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