Jackson Multipurpose Operating Table

FDA 510(k) K910736 · Orthopedic Systems, Inc.

Substantially Equivalent

510(k) numberK910736

Submission

Device name
Jackson Multipurpose Operating Table
Applicant
Orthopedic Systems, Inc.
Hayward, CA, US
Received
February 21, 1991
Decision date
May 21, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 878.4960
Specialty
General, Plastic Surgery

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K894283Comprehensive Spine Motion AnalyzerKQX · Traditional 01/19/1990SE
K890498Freeman Modular Hip Stem Ridged VersionJDI · Traditional 10/13/1989SN
K890331Freeman Total Hip System Ridged StemLWJ · Traditional 10/13/1989SE
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Questions and answers

When was Jackson Multipurpose Operating Table cleared by the FDA?

Jackson Multipurpose Operating Table (K910736) received a 510(k) decision of Substantially Equivalent on May 21, 1991, 89 days after the submission was received.

What is the product code of K910736?

The FDA product code is JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.