K Orthopedic Table

FDA 510(k) K881101 · Instrumentation Specialties, Inc.

Substantially Equivalent

510(k) numberK881101

Submission

Device name
K Orthopedic Table
Applicant
Instrumentation Specialties, Inc.
San Antonio, TX, US
Received
March 15, 1988
Decision date
April 6, 1988
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
K905816Orthovision TableJEB · Traditional American Sterilizer Co.03/06/1991SE
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
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
K925005Isi Self-Supporting ArmBWN · Traditional 04/29/1993SE

Questions and answers

When was K Orthopedic Table cleared by the FDA?

K Orthopedic Table (K881101) received a 510(k) decision of Substantially Equivalent on April 6, 1988, 22 days after the submission was received.

What is the product code of K881101?

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