Vertetrac

FDA 510(k) K771988 · Ballert Orthopedic Corp.

Substantially Equivalent

510(k) numberK771988

Submission

Device name
Vertetrac
Applicant
Ballert Orthopedic Corp.
Mchenry, IL, US
Received
October 19, 1977
Decision date
February 1, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HST – Apparatus, Traction, Non-Powered
Device class
Class I (low risk)
Regulation
21 CFR 888.5850
Specialty
Orthopedic

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K984190Back-On-Trac, Model 101BOTHST · Traditional Back-On-Track, Inc.03/15/1999SE
K872121K and D Home TractHST · Traditional Joseph A. Kott, M.D.08/12/1987SE
K870212Arthroscopic Shoulder HolderHST · Traditional Dyonics, Inc.02/20/1987SE
K870125Extremity ElevatorHST · Traditional Orthopedic Systems, Inc.02/04/1987SE
K870102Tupper TrolleyHST · Traditional Orthopedic Systems, Inc.02/03/1987SE
K864765Model 668, Traction Splint, AdultHST · Traditional Ferno-Washington, Inc.12/17/1986SE
K862874The Towered 90/90 UnitHST · Traditional Lossing Orthopedic, Inc.08/07/1986SE
K860037Suspender Orthopedic Suspension DeviceHST · Traditional Comfortex, Inc.01/21/1986SE

More from Comfortex, Inc.

510(k)DeviceDecision
K780617EqualizerIPG · Traditional 04/18/1978SE

Questions and answers

When was Vertetrac cleared by the FDA?

Vertetrac (K771988) received a 510(k) decision of Substantially Equivalent on February 1, 1979, 470 days after the submission was received.

What is the product code of K771988?

The FDA product code is HST – Apparatus, Traction, Non-Powered, a Class I (low risk) device regulated under 21 CFR 888.5850.