Casf Drill Guide DG 170

FDA 510(k) K882871 · Terray Manufacturing, Inc.

Substantially Equivalent for Some Indications

510(k) numberK882871

Submission

Device name
Casf Drill Guide DG 170
Applicant
Terray Manufacturing, Inc.
Ontario K7s 1l8, CA
Received
July 11, 1988
Decision date
September 23, 1988
Decision
Substantially Equivalent for Some Indications (SN)
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
K893415Trans-Oral Depth GaugeLYQ · Traditional Ruggles Corp.06/07/1989SE
K883784TSRH Anterior Spinal Screws, Staples and End PlateLYQ · Traditional Warsaw Orthopedic, Inc.04/06/1989SN

More from Warsaw Orthopedic, Inc.

510(k)DeviceDecision
K910874Thoracic Anterior Spinal Fixation PlateKWQ · Traditional 02/03/1992SE
K882934Casf Cancellous Bone Screw, BT650HWC · Traditional 10/13/1988SE
K883193Casf Sterilization TrayFSM · Traditional 08/10/1988SE
K883125Casf Sterilization TrayFSM · Traditional 08/10/1988SE
K870085Anterior Spinal Fixation PlateKWP · Traditional 06/30/1987SE
K870082Bone PlateHRS · Traditional 05/06/1987SE
K870083Ferray ExtractorHWB · Traditional 02/26/1987SE
K870084RD 140 Surgical BenderHXW · Traditional 01/28/1987SE

Questions and answers

When was Casf Drill Guide DG 170 cleared by the FDA?

Casf Drill Guide DG 170 (K882871) received a 510(k) decision of Substantially Equivalent for Some Indications on September 23, 1988, 74 days after the submission was received.

What is the product code of K882871?

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