HemiCAP MTP Resurfacing Hemi-Arthroplasty System— 510(k) K152454

Substantially Equivalent

Arthrosurface, Inc.

FDA 510(k) clearance K152454 for HemiCAP MTP Resurfacing Hemi-Arthroplasty System, Substantially Equivalent on 2016-04-11. Applicant: Arthrosurface, Inc..

Clearance details

Applicant: Arthrosurface, Inc.
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 2015-08-28
Decision date: 2016-04-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Franklin, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWD

product code KWD

Injury: 164
Total: 164

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.