OPTEON UNIPOLAR— 510(k) K960538

Name: FDA 510(k) clearance K960538
Creator: U.S. Food and Drug Administration
Published: 1996-03-27

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K960538 for OPTEON UNIPOLAR, Substantially Equivalent on 1996-03-27. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant: Exactech, Inc.
Product code: Code KWL
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1996-02-07
Decision date: 1996-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWL

view all

K262290 — REMEDY POLY+PLUS SNAP FIT Acetabular Cup2026-07-24
K260536 — Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement2026-05-15
K253675 — OsteoRemedies Hip Spacer System2025-12-23
K252326 — InterSpace GV Hip Spacer2025-08-06
K242865 — Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer2025-06-12

More clearances from Exactech, Inc.

view all

K260583 — Equinoxe® Shoulder System2026-04-14
K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
K243448 — Equinoxe® Shoulder System2025-08-01
K243275 — Equinoxe® Scapula Fracture System2025-06-26
K243839 — Alteon® HA Femoral Stems2025-03-10

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.