PIPELINE TOTAL HIP SYSTEM— 510(k) K112802

Substantially Equivalent

Pipeline Orthopedics

FDA 510(k) clearance K112802 for PIPELINE TOTAL HIP SYSTEM, Substantially Equivalent on 2012-03-09. Applicant: Pipeline Orthopedics. Device class: 2.

Clearance details

Applicant
Pipeline Orthopedics
Product code
Code OQG
Device class
Class 2
Regulation
21 CFR 888.3358
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Alexandria, VA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OQG

product code OQG
Injury
249
Total
249

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.