Spinal Wrench

FDA 510(k) K813067 · Twin City Surgical, Inc.

Substantially Equivalent

510(k) numberK813067

Submission

Device name
Spinal Wrench
Applicant
Twin City Surgical, Inc.
Mchenry, IL, US
Received
October 30, 1981
Decision date
November 24, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HXC – Wrench
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Specialty
Orthopedic

Other 510(k)s with product code HXC

510(k)DeviceApplicantDecision
K180092IntellitorqHXC · Traditional Gauthier Biomedical, Inc.03/08/2018SE
K874359Adjustable WrenchesHXC · Traditional Med-Tool, Inc.11/23/1987SE
K874358Combination WrenchesHXC · Traditional Med-Tool, Inc.11/23/1987SE
K870053Torquedriver WrenchHXC · Traditional Jerome Medical03/11/1987SE
K791073WrenchHXC · Traditional Truth, Inc.06/20/1979SE

More from Truth, Inc.

510(k)DeviceDecision
K870767The (Crom) TesterKQW · Traditional 03/17/1987SE
K861632Sims ChairIKK · Traditional 05/27/1986SE
K830585Anvil RetractorGAD · Traditional 05/27/1983SE
K820660A Hook DriverKWP · Traditional 03/19/1982SE
K820659A CaliperKTZ · Traditional 03/19/1982SE

Questions and answers

When was Spinal Wrench cleared by the FDA?

Spinal Wrench (K813067) received a 510(k) decision of Substantially Equivalent on November 24, 1981, 25 days after the submission was received.

What is the product code of K813067?

The FDA product code is HXC – Wrench, a Class I (low risk) device regulated under 21 CFR 888.4540.