Levtech Composite Traction Tongs

FDA 510(k) K873693 · Levtech, Inc.

Substantially Equivalent

510(k) numberK873693

Submission

Device name
Levtech Composite Traction Tongs
Applicant
Levtech, Inc.
Jacksonville, FL, US
Received
September 14, 1987
Decision date
February 5, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HAX – Tong, Skull For Traction
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5960
Specialty
Neurology

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K051918Resolve Open Back Halo RingsHAX · Special Jerome Medical08/17/2005SE
K023959Jerome Glass RingHAX · Traditional The Jerome Group, Inc.02/21/2003SE
K003662Spine Works CollarHAX · Traditional Spine Works07/09/2001SE
K980689Friddle Halo System, Friddle MRI Halo SystemHAX · Traditional Friddle'S Orthopedic Appliances, Inc.02/18/1999SE
K930021J TongsHAX · Traditional Jerome Medical12/06/1995SE
K954069Ace Cervical Traction Halozs, Tongs & PinsHAX · Traditional Ace Medical Co.10/12/1995SE
K924606Bremer Imaging Tongs-Mri ModelHAX · Traditional Bremer Medical, Inc.09/09/1993SE
K915530Nova Gauze(R) Disposable Nonwoven Sponges, SterileHAX · Traditional American Threshold Industries, Inc.08/17/1992SE

More from American Threshold Industries, Inc.

510(k)DeviceDecision
K910128Levtech Titanium Bone WireJDQ · Traditional 06/18/1991SE
K901144Levtech Bone ScrewHWC · Traditional 10/10/1990SE
K874023Levtech Clamp ApplierHTD · Traditional 11/06/1987SE
K850039Halifax Spinal ClampKWP · Traditional 05/29/1985SE

Questions and answers

When was Levtech Composite Traction Tongs cleared by the FDA?

Levtech Composite Traction Tongs (K873693) received a 510(k) decision of Substantially Equivalent on February 5, 1988, 144 days after the submission was received.

What is the product code of K873693?

The FDA product code is HAX – Tong, Skull For Traction, a Class II (moderate risk) device regulated under 21 CFR 882.5960.