BIO-FIT HIP SYSTEM— 510(k) K854791

Name: FDA 510(k) clearance K854791
Creator: U.S. Food and Drug Administration
Published: 1986-02-27

Substantially Equivalent

Richards Medical Co., Inc.

FDA 510(k) clearance K854791 for BIO-FIT HIP SYSTEM, Substantially Equivalent on 1986-02-27. Applicant: Richards Medical Co., Inc.. Device class: 2.

Clearance details

Applicant: Richards Medical Co., Inc.
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1985-11-29
Decision date: 1986-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer2025-06-12

More clearances from Richards Medical Co., Inc.

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K896106 — ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTS1990-06-25
K900628 — MODULAR HIP SYSTEM1990-05-09
K896580 — UNI-POLAR HEAD1990-02-15
K895241 — INTRAMEDULLARY HIP SCREW1990-01-04
K884824 — TRICON-M TOTAL KNEE SYSTEM1989-11-21

Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.