SAGITTAL KNEE TESTER— 510(k) K831041

Substantially Equivalent

Orthopedic Systems, Inc.

FDA 510(k) clearance K831041 for SAGITTAL KNEE TESTER, Substantially Equivalent on 1983-06-24. Applicant: Orthopedic Systems, Inc.. Device class: 1.

Clearance details

Applicant: Orthopedic Systems, Inc.
Product code: Code FTY
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1983-03-31
Decision date: 1983-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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