Cover Limb

FDA 510(k) K823399 · Orthopedic Systems, Inc.

Substantially Equivalent

510(k) numberK823399

Submission

Device name
Cover Limb
Applicant
Orthopedic Systems, Inc.
Mchenry, IL, US
Received
November 12, 1982
Decision date
November 29, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IPM – Cover, Limb
Device class
Class I (low risk)
Regulation
21 CFR 890.3025
Specialty
Physical Medicine

Other 510(k)s with product code IPM

510(k)DeviceApplicantDecision
K872488Elasto-Gel Cast & Splint PadsIPM · Traditional Southwest Technologies, Inc.09/21/1987SN
K801627Cover, LimbIPM · Traditional The Owenby Co.07/28/1980SE
K780905Limb CoverIPM · Traditional Hydro-Med Products, Inc.08/14/1978SE
K770223Heavy Foam Heel & Elbow ProtectorsIPM · Traditional Robert R. Moore02/23/1977SE
K761114Foam SlippersIPM · Traditional Fred Sammons, Inc.12/02/1976SE

More from Fred Sammons, 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 Cover Limb cleared by the FDA?

Cover Limb (K823399) received a 510(k) decision of Substantially Equivalent on November 29, 1982, 17 days after the submission was received.

What is the product code of K823399?

The FDA product code is IPM – Cover, Limb, a Class I (low risk) device regulated under 21 CFR 890.3025.