PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE— 510(k) K141711

Name: FDA 510(k) clearance K141711
Creator: U.S. Food and Drug Administration
Published: 2014-07-24

Substantially Equivalent

Pontis Orthopaeeics, LLC

FDA 510(k) clearance K141711 for PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE, Substantially Equivalent on 2014-07-24. Applicant: Pontis Orthopaeeics, LLC. Device class: 2.

Clearance details

Applicant: Pontis Orthopaeeics, LLC
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2014-06-25
Decision date: 2014-07-24
Decision: Substantially Equivalent
Clearance type: Special
Location: San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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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, 2020-01-01 through 2026-04-23. 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.