K-Wires and Steinmann Pins

FDA 510(k) K941434 · Omega Surgical Instruments, Inc.

Substantially Equivalent

510(k) numberK941434

Submission

Device name
K-Wires and Steinmann Pins
Applicant
Omega Surgical Instruments, Inc.
Grand Blanc, MI, US
Received
March 24, 1994
Decision date
October 3, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HTY – Pin, Fixation, Smooth
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3040
Specialty
Orthopedic
Implant
Yes

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K241014Biomet Kirschner Wires (K-Wires)HTY · Traditional Biomet, Inc.05/22/2024SE
K231272OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable…HTY · Traditional OSSIO , Ltd.12/01/2023SE
K231147Hammerdesis™ Interphalangeal Fusion SystemHTY · Traditional Intelivation09/14/2023SE
K230750OSSIOfiber® Cannulated Trimmable Fixation NailHTY · Traditional OSSIO , Ltd.09/13/2023SE

More from OSSIO , Ltd.

510(k)DeviceDecision
K933595Bur, Surgical, General & Plastic SurgeryGFA · Traditional 03/16/1994SE
K933298Saw BladeGFA · Traditional 08/09/1993SE

Questions and answers

When was K-Wires and Steinmann Pins cleared by the FDA?

K-Wires and Steinmann Pins (K941434) received a 510(k) decision of Substantially Equivalent on October 3, 1994, 193 days after the submission was received.

What is the product code of K941434?

The FDA product code is HTY – Pin, Fixation, Smooth, a Class II (moderate risk) device regulated under 21 CFR 888.3040.