IONGUARD TITANIUM MODULAR HEADS— 510(k) K915548

Name: FDA 510(k) clearance K915548
Creator: U.S. Food and Drug Administration
Published: 1992-03-10

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K915548 for IONGUARD TITANIUM MODULAR HEADS, Substantially Equivalent on 1992-03-10. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code LZY
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1991-12-11
Decision date: 1992-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZY

view all

K231448 — TANDEM Hip System2023-07-19
K111145 — ENDO HEAD2011-08-16
K974442 — PRE-POWDERED NITRILE EXAMINATION GLOVES1998-01-05
K915528 — BHR BIPOLAR FEMORAL HEAD COMPONENT1993-06-29
K903084 — MODULAR CATHCART FRACTURE SYSTEM1990-10-03

More clearances from Biomet, Inc.

view all

K253434 — OSSTM Orthopedic Salvage System2026-07-01
K251270 — Taperloc® Complete Hip Stem2026-05-19
K241014 — Biomet Kirschner Wires (K-Wires)2024-05-22
K222760 — StageOne Select Hip Cement Spacer Molds2022-12-28
K221968 — StageOne Shoulder Cement Spacer Molds2022-09-15

Adverse events under product code LZY

product code LZY

Injury: 431
Total: 431

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.