Trans-Oral Depth Gauge

FDA 510(k) K893415 · Ruggles Corp.

Substantially Equivalent

510(k) numberK893415

Submission

Device name
Trans-Oral Depth Gauge
Applicant
Ruggles Corp.
No. Quincy, MA, US
Received
May 2, 1989
Decision date
June 7, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LYQ – Accessories, Fixation, Spinal Intervertebral Body
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Specialty
Orthopedic

Other 510(k)s with product code LYQ

510(k)DeviceApplicantDecision
K883784TSRH Anterior Spinal Screws, Staples and End PlateLYQ · Traditional Warsaw Orthopedic, Inc.04/06/1989SN
K882871Casf Drill Guide DG 170LYQ · Traditional Terray Manufacturing, Inc.09/23/1988SN

More from Terray Manufacturing, Inc.

510(k)DeviceDecision
K903485Titanium MeshGWO · Traditional 02/21/1991SE
K902818Multiple Nonpowered Neurosurgical InstrumentHBG · Traditional 09/20/1990SE
K902819Laminectomy RogeurLXH · Traditional 08/09/1990SE
K902850Zeppelin InstrumentsHAO · Traditional 07/18/1990SE

Questions and answers

When was Trans-Oral Depth Gauge cleared by the FDA?

Trans-Oral Depth Gauge (K893415) received a 510(k) decision of Substantially Equivalent on June 7, 1989, 36 days after the submission was received.

What is the product code of K893415?

The FDA product code is LYQ – Accessories, Fixation, Spinal Intervertebral Body, a Class I (low risk) device regulated under 21 CFR 888.4540.