PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS— 510(k) K101126

Substantially Equivalent

Core Essence Orthopaedics, Inc.

FDA 510(k) clearance K101126 for PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS, Substantially Equivalent on 2010-12-02. Applicant: Core Essence Orthopaedics, Inc..

Clearance details

Applicant: Core Essence Orthopaedics, Inc.
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2010-04-22
Decision date: 2010-12-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft Washington, PA, US

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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.