Plaster Stand

FDA 510(k) K870100 · Orthopedic Systems, Inc.

Substantially Equivalent

510(k) numberK870100

Submission

Device name
Plaster Stand
Applicant
Orthopedic Systems, Inc.
Hayward, CA, US
Received
January 9, 1987
Decision date
January 28, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LGG – Instrument, Cast Application/Removal, Manual
Device class
Class I (low risk)
Regulation
21 CFR 888.5980
Specialty
Orthopedic

Other 510(k)s with product code LGG

510(k)DeviceApplicantDecision
K85178627-230 to 27-234 Various Cast Breakers, WolfLGG · Traditional Artiberia07/09/1985SE
K834384Modular Extremity Casting SupportLGG · Traditional Buckman Co., Inc.01/30/1984SE

More from Buckman Co., 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 Plaster Stand cleared by the FDA?

Plaster Stand (K870100) received a 510(k) decision of Substantially Equivalent on January 28, 1987, 19 days after the submission was received.

What is the product code of K870100?

The FDA product code is LGG – Instrument, Cast Application/Removal, Manual, a Class I (low risk) device regulated under 21 CFR 888.5980.