PRO-LINK WEDGE SYSTEM— 510(k) K141905

Name: FDA 510(k) clearance K141905
Creator: U.S. Food and Drug Administration
Published: 2014-09-26

Substantially Equivalent

Life Spine

FDA 510(k) clearance K141905 for PRO-LINK WEDGE SYSTEM, Substantially Equivalent on 2014-09-26. Applicant: Life Spine. Device class: 2.

Clearance details

Applicant: Life Spine
Product code: Code HRS
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2014-07-15
Decision date: 2014-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoffman Estates, IL, US

Download summary PDF View on FDA.gov ↗

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K260277 — MIKRON TRAUMA BONE PLATE& SCREW SYSTEM2026-08-13
K261511 — Xpert Ankle2026-07-28

More clearances from Life Spine

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K182470 — Plateau Spacer System2018-11-26
K160169 — The Life Spine Subtalar Implant System2016-06-23
K150368 — Tarsa-Link Wedge Fixation System2015-03-24
K133717 — LONGBOW SPACER SYSTEM2014-09-19
K131077 — LIFE SPINE PLATEAU SPACER SYSTEM2013-07-17

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.