Bur, Surgical Carbide

FDA 510(k) K760236 · Cutter Laboratories, Inc.

Substantially Equivalent

510(k) numberK760236

Submission

Device name
Bur, Surgical Carbide
Applicant
Cutter Laboratories, Inc.
Mchenry, IL, US
Received
July 15, 1976
Decision date
July 26, 1976
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HTT – Burr, Orthopedic
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Specialty
Orthopedic

Other 510(k)s with product code HTT

510(k)DeviceApplicantDecision
K862529Hall Sterile BurHTT · Traditional Hall Surgical, Division of Zimmer, Inc.07/15/1986SE
K821695Micro-Aire Replac. Drill Burs for ZimmerHTT · Traditional Micro-Aire Surgical Instruments, Inc.07/20/1982SE
K802598Carbide Cutting Instrument/IntraarticuHTT · Traditional The Anspach Effort, Inc.11/19/1980SE

More from The Anspach Effort, Inc.

510(k)DeviceDecision
K861315Hyperbaric Penetration Extension SetCBF · Traditional 05/21/1986SE
K854106BaysilexELW · Traditional 03/17/1986SE
K842324PerfourmELW · Traditional 11/09/1984SE
K834106Intravenous Infusion ControllerLDR · Traditional 05/30/1984SE
K832237Orthopedic Casting Tape MaxcastITG · Traditional 08/16/1983SE
K823214Dosimetric Release Program - Admin. SetFPA · Traditional 01/12/1983SE
K821326Cutter Bond Polycarboxylate CementEMA · Traditional 05/28/1982SE
K813532Cutterbond Zinc Phosphate CementEMA · Traditional 03/02/1982SE
K802105C-BladeHWE · Traditional 09/16/1980SE
K802104C-SplintIQI · Traditional 09/16/1980SE

Questions and answers

When was Bur, Surgical Carbide cleared by the FDA?

Bur, Surgical Carbide (K760236) received a 510(k) decision of Substantially Equivalent on July 26, 1976, 11 days after the submission was received.

What is the product code of K760236?

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