TI-FIT TOTAL HIP SYSTEM— 510(k) K873797

Name: FDA 510(k) clearance K873797
Creator: U.S. Food and Drug Administration
Published: 1987-11-02

Substantially Equivalent

Richards Medical Co., Inc.

FDA 510(k) clearance K873797 for TI-FIT TOTAL HIP SYSTEM, Substantially Equivalent on 1987-11-02. Applicant: Richards Medical Co., Inc.. Device class: 2.

Clearance details

Applicant: Richards Medical Co., Inc.
Product code: Code LWJ
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1987-09-18
Decision date: 1987-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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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 LWJ

product code LWJ

Injury: 544
Total: 544

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.