BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD— 510(k) K953045

Name: FDA 510(k) clearance K953045
Creator: U.S. Food and Drug Administration
Published: 1995-09-27

Substantially Equivalent for Some Indications

Biologically Oriented Prostheses

FDA 510(k) clearance K953045 for BIOPRO HEMI-ENDO MODULAR CERAMIC HEAD, Substantially Equivalent for Some Indications on 1995-09-27. Applicant: Biologically Oriented Prostheses. Device class: 2.

Clearance details

Applicant: Biologically Oriented Prostheses
Product code: Code LZO
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 1995-06-30
Decision date: 1995-09-27
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Port Huron, MI, US

Download summary PDF View on FDA.gov ↗

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K002325 — WUJIN #3 TIBIAL NAIL2000-10-30
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K964472 — RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT1997-02-03
K962769 — HORIZON HIP SYSTEM1996-10-03
K955916 — TOWNLEY TOTAL ELBOW SYSTEM1996-08-08

Adverse events under product code LZO

product code LZO

Death: 17
Injury: 12,942
Malfunction: 1,756
Total: 14,715

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.