Snap Sternum Saw

FDA 510(k) K935517 · Surgiquip, Inc.

Substantially Equivalent

510(k) numberK935517

Submission

Device name
Snap Sternum Saw
Applicant
Surgiquip, Inc.
Dallas, TX, US
Received
November 18, 1993
Decision date
March 10, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HAB – Saw, Powered, And Accessories
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Specialty
General, Plastic Surgery

Other 510(k)s with product code HAB

510(k)DeviceApplicantDecision
K012320Powerpro Battery SystemHAB · Traditional Linvatec Corp.10/19/2001SE

More from Linvatec Corp.

510(k)DeviceDecision
K935357Snap Reciprocating SawGAF · Traditional 01/28/1994SE
K935322Snap Bone ReamerHWE · Traditional 01/28/1994SE
K935516Snap DrillHWE · Traditional 01/27/1994SE
K931769Snap Oscillating SawGFA · Traditional 01/27/1994SE

Questions and answers

When was Snap Sternum Saw cleared by the FDA?

Snap Sternum Saw (K935517) received a 510(k) decision of Substantially Equivalent on March 10, 1994, 112 days after the submission was received.

What is the product code of K935517?

The FDA product code is HAB – Saw, Powered, And Accessories, a Class I (low risk) device regulated under 21 CFR 878.4820.