Comprehensive SRS/Nexel Elbow— 510(k) K153398

Name: FDA 510(k) clearance K153398
Creator: U.S. Food and Drug Administration
Published: 2016-02-03

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K153398 for Comprehensive SRS/Nexel Elbow, Substantially Equivalent on 2016-02-03. Applicant: Biomet Manufacturing Corp. Device class: 2.

Clearance details

Applicant: Biomet Manufacturing Corp
Product code: Code JDC
Device class: Class 2
Regulation: 21 CFR 888.3150
Advisory panel: Orthopedic
Date received: 2015-11-24
Decision date: 2016-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDC

view all

K181362 — TEMA Elbow System2019-02-16
K181307 — Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow2019-01-28
K150501 — Zimmer Nexel Total Elbow Ulnar Cement Diverter2015-04-23
K123862 — ZIMMER NEXEL TOTAL ELBOW2013-03-12
K090473 — DISCOVERY ELBOW - X-SMALL2009-03-25

More clearances from Biomet Manufacturing Corp

view all

K230540 — Patient Specific Planning Solution 3D Bone Models2023-07-25
K214001 — Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System2023-03-15
K211729 — Comprehensive® Convertible Glenoid - Vivacit-E Liner2021-11-04
K202232 — Comprehensive Vault Reconstruction System2021-02-19
K193038 — Comprehensive Shoulder System2020-10-28

Adverse events under product code JDC

product code JDC

Injury: 1,050
Total: 1,050

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.