Life Spine Metatarsal Hemi Implant— 510(k) K161279

Substantially Equivalent

Life Spine, Inc.

FDA 510(k) clearance K161279 for Life Spine Metatarsal Hemi Implant, Substantially Equivalent on 2017-02-01. Applicant: Life Spine, Inc..

Clearance details

Applicant: Life Spine, Inc.
Product code: Code KWD
Advisory panel: Orthopedic
Date received: 2016-05-06
Decision date: 2017-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntley, IL, 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.