Orthovision Table

FDA 510(k) K905816 · American Sterilizer Co.

Substantially Equivalent

510(k) numberK905816

Submission

Device name
Orthovision Table
Applicant
American Sterilizer Co.
Erie, PA, US
Received
December 28, 1990
Decision date
March 6, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JEB – Table, Surgical With Orthopedic Accessories, Manual
Device class
Class I (low risk)
Regulation
21 CFR 878.4950
Specialty
General, Plastic Surgery

Other 510(k)s with product code JEB

510(k)DeviceApplicantDecision
K900405Scholten FrameJEB · Traditional Scholten Surgical Instruments, Inc.03/01/1990SE
K891917Ortho-J, Inc. BEK-JS-004JEB · Traditional Ortho-J, Inc.05/26/1989SE
K891387Williams Belt & BootJEB · Traditional Arthro-Medic, Inc.05/23/1989SE
K881101K Orthopedic TableJEB · Traditional Instrumentation Specialties, Inc.04/06/1988SE
K880263Osi Rizzoli Orthopedic Table/Manual VersionJEB · Traditional Orthopedic Systems, Inc.03/15/1988SE
K873276Extension Device 1416JEB · Traditional Stierlen-Maquet AG09/17/1987SE
K873275Extension Table 1417JEB · Traditional Stierlen-Maquet AG09/17/1987SE
K873274Plaster Table 1418JEB · Traditional Stierlen-Maquet AG09/17/1987SE
K873273Orthopaedic Table 1420JEB · Traditional Stierlen-Maquet AG09/17/1987SE
K781082Cast BlockJEB · Traditional Orthopedic Equipment Co., Inc.07/07/1978SE

More from Orthopedic Equipment Co., Inc.

510(k)DeviceDecision
K943288Amsco SQ240 Surgical LightFSY · Traditional 10/17/1994SE
K931872The Eagle 3017 100% Ethylene Oxide SterilizerFLF · Traditional 02/07/1994SE
K922485Chemdi-Vhp Chemical IndicatorJOJ · Traditional 09/29/1993SE
K930493Quantum 3080 Surgical TableFQO · Traditional 06/22/1993SE
K896674Amsco Quantum LightFSY · Traditional 01/03/1990SE
K895164Eagle DSECG · Traditional 11/17/1989SE
K882660General Surgical Table and AccessoriesFQO · Traditional 07/25/1988SE
K880198Gemini Surgical LightFSS · Traditional 02/10/1988SE
K864846Radiographic - Leg SectionKQS · Traditional 12/24/1986SE
K844479ChemsporFRC · Traditional 11/25/1985SN

Questions and answers

When was Orthovision Table cleared by the FDA?

Orthovision Table (K905816) received a 510(k) decision of Substantially Equivalent on March 6, 1991, 68 days after the submission was received.

What is the product code of K905816?

The FDA product code is JEB – Table, Surgical With Orthopedic Accessories, Manual, a Class I (low risk) device regulated under 21 CFR 878.4950.