BIOPRO FEMORAL HIP COMPONENT— 510(k) K872535

Name: FDA 510(k) clearance K872535
Creator: U.S. Food and Drug Administration
Published: 1987-08-26

Substantially Equivalent

Biopro, Inc.

FDA 510(k) clearance K872535 for BIOPRO FEMORAL HIP COMPONENT, Substantially Equivalent on 1987-08-26. Applicant: Biopro, Inc.. Device class: 2.

Clearance details

Applicant: Biopro, Inc.
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1987-06-26
Decision date: 1987-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, US

Download summary PDF View on FDA.gov ↗

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K252326 — InterSpace GV Hip Spacer2025-08-06
K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer2025-06-12

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K163627 — Shotel Ankle Arthrodesis Nail System2017-09-14
K162674 — BioPro Foot Plating Systems2017-06-16
K132510 — BIOPRO - INFINITY PLATE ANCHOR SYSTEM2013-10-24
K130298 — BIOPRO KWICK-WIRE UNIVERSAL SCREW SYSTEM2013-06-18
K121973 — BIOPRO HEMI-EDGE TOE SYSTEM2012-10-30

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.