Lateral Positioner

FDA 510(k) K823398 · Orthopedic Systems, Inc.

Substantially Equivalent

510(k) numberK823398

Submission

Device name
Lateral Positioner
Applicant
Orthopedic Systems, Inc.
Mchenry, IL, US
Received
November 12, 1982
Decision date
November 24, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

No product code recorded.

More from Orthopedic Systems, Inc.

510(k)DeviceDecision
K952495Anchors Away Soft Tissue Attachment SystemLXH · Traditional 01/22/1996SE
K920256Spine Motion Analyzer with EmgKQX · Traditional 08/10/1992SE
K910736Jackson Multipurpose Operating TableJEA · Traditional 05/21/1991SE
K910031Park City Shoulder PositionerFWZ · Traditional 01/24/1991SE
K903938C Fit CupJDI · Traditional 01/04/1991SN
K892503Nuffield Total KneeJWH · Traditional 05/04/1990SN
K896678Silicone PlugHRX · Traditional 01/30/1990SE
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

Questions and answers

When was Lateral Positioner cleared by the FDA?

Lateral Positioner (K823398) received a 510(k) decision of Substantially Equivalent on November 24, 1982, 12 days after the submission was received.