SAGITTAL & ROTARY ACT/PASS KNEE LIGAMENT TESTER— 510(k) K861622

Name: FDA 510(k) clearance K861622
Creator: U.S. Food and Drug Administration
Published: 1986-05-27

Substantially Equivalent

Orthopedic Systems, Inc.

FDA 510(k) clearance K861622 for SAGITTAL & ROTARY ACT/PASS KNEE LIGAMENT TESTER, Substantially Equivalent on 1986-05-27. Applicant: Orthopedic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: Code IKK
Device class: Class 2
Regulation: 21 CFR 890.1925
Advisory panel: Physical Medicine
Date received: 1986-04-29
Decision date: 1986-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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