MODIFIED FREEMAN REVISION ACETABULAR CUP— 510(k) K902111

Name: FDA 510(k) clearance K902111
Creator: U.S. Food and Drug Administration
Published: 1990-08-22

Substantially Equivalent

Turnkey Intergration USA, Inc.

FDA 510(k) clearance K902111 for MODIFIED FREEMAN REVISION ACETABULAR CUP, Substantially Equivalent on 1990-08-22. Applicant: Turnkey Intergration USA, Inc.. Device class: 3.

Clearance details

Applicant: Turnkey Intergration USA, Inc.
Product code: Code KWA
Device class: Class 3
Regulation: 21 CFR 888.3330
Advisory panel: Orthopedic
Date received: 1990-05-09
Decision date: 1990-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K113271 — METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS2012-05-18
K113322 — CONSERVE THIN SHELL2012-02-03
K112080 — PRESERVE HIP STEM2011-12-28

More clearances from Turnkey Intergration USA, Inc.

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K991405 — OMNI-FIX, HUMERAL NAIL1999-06-29
K990523 — B2C, ESPACE REVISION CUP SYSTEM1999-04-30
K990307 — OMNI-FIX, NAIL SYSTEM1999-04-01
K972411 — LINK CEMENT PLUG1997-08-29
K970284 — ARTOS, DIPLOS SYSTEM1997-04-21

Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

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.