SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.— 510(k) K870923

Name: FDA 510(k) clearance K870923
Creator: U.S. Food and Drug Administration
Published: 1987-09-14

Substantially Equivalent

Protek, Inc.

FDA 510(k) clearance K870923 for SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX., Substantially Equivalent on 1987-09-14. Applicant: Protek, Inc.. Device class: 3.

Clearance details

Applicant: Protek, Inc.
Product code: Code KWA
Device class: Class 3
Regulation: 21 CFR 888.3330
Advisory panel: Orthopedic
Date received: 1987-03-04
Decision date: 1987-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K121544 — DYNASTY BIOFOAM SHELL2012-07-30
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 Protek, Inc.

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K893785 — ARC-2F ACETABULAR CUP1989-08-09
K893959 — P.S.A. FEMORAL HIP PROSTHESIS1989-07-25
K892059 — FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR1989-07-19
K883794 — RESUBMITTED CLW ACETABULAR CUP W/SULMESH1989-05-26
K884952 — VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC1989-05-10

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.