BIOPRO BIPOLAR HEAD, MODELS 18130-18152— 510(k) K082705

Name: FDA 510(k) clearance K082705
Creator: U.S. Food and Drug Administration
Published: 2008-12-15

Substantially Equivalent

Biopro, Inc.

FDA 510(k) clearance K082705 for BIOPRO BIPOLAR HEAD, MODELS 18130-18152, Substantially Equivalent on 2008-12-15. Applicant: Biopro, Inc.. Device class: 2.

Clearance details

Applicant: Biopro, Inc.
Product code: Code KWY
Device class: Class 2
Regulation: 21 CFR 888.3390
Advisory panel: Orthopedic
Date received: 2008-09-16
Decision date: 2008-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Huron, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWY

view all

K253357 — b-ONE® Bipolar Head2026-04-13
K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip)2025-08-25
K231526 — CORAIL Cemented Femoral Stem2023-12-19
K223441 — SpaceFlex Acetabular Cup2023-03-23
K221794 — Vario-Cup System2022-07-20

More clearances from Biopro, Inc.

view all

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 KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.