BIOPHASE IMPLANT MATERIAL— 510(k) K792329

Name: FDA 510(k) clearance K792329
Creator: U.S. Food and Drug Administration
Published: 1980-01-23

Substantially Equivalent

Richard'S Medical Equip., Inc.

FDA 510(k) clearance K792329 for BIOPHASE IMPLANT MATERIAL, Substantially Equivalent on 1980-01-23. Applicant: Richard'S Medical Equip., Inc.. Device class: 2.

Clearance details

Applicant: Richard'S Medical Equip., Inc.
Product code: Code JDG
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1979-11-19
Decision date: 1980-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K823723 — SPECTRON PROXIMAL FEMORAL PROSTHESIS1983-03-09
K823724 — SPECTRON NECK REPLACEMENT PROSTHESIS1983-03-09
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Adverse events under product code JDG

product code JDG

Injury: 804
Malfunction: 3,242
Total: 4,046

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.