DeviceClearance

ORTHOFIX GALAXY FIXATION SYSTEM— 510(k) K113770

Substantially Equivalent

Orthofix Srl

FDA 510(k) clearance K113770 for ORTHOFIX GALAXY FIXATION SYSTEM, Substantially Equivalent on 2012-09-04. Applicant: Orthofix Srl. Device class: 2.

Clearance details

Applicant
Orthofix Srl
Product code
Code KTT
Device class
Class 2
Regulation
21 CFR 888.3030
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Oregon City, OR, US
Download summary PDFView on FDA.gov ↗

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More clearances from Orthofix Srl

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Adverse events under product code KTT

product code KTT
Death
11
Injury
3,097
Malfunction
1,261
Total
4,369

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 K113770

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 K113770.

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