NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI— 510(k) K884789

Name: FDA 510(k) clearance K884789
Creator: U.S. Food and Drug Administration
Published: 1989-02-08

Substantially Equivalent for Some Indications

Protek, Inc.

FDA 510(k) clearance K884789 for NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI, Substantially Equivalent for Some Indications on 1989-02-08. Applicant: Protek, Inc.. Device class: 2.

Clearance details

Applicant: Protek, Inc.
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1988-11-15
Decision date: 1989-02-08
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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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 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.