Tracer Bone Mill

FDA 510(k) K883183 · De Medica Mfg., Inc.

Substantially Equivalent

510(k) numberK883183

Submission

Device name
Tracer Bone Mill
Applicant
De Medica Mfg., Inc.
Santa Paula, CA, US
Received
July 28, 1988
Decision date
October 12, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LYS – Bone Mill
Device class
Class I (low risk)
Regulation
21 CFR 888.4540
Specialty
Orthopedic

Other 510(k)s with product code LYS

510(k)DeviceApplicantDecision
K860356Orthoblend Powered Bone MillLYS · Traditional Zimmer, Inc.07/08/1986SE
K861164Osteomill Bone GrinderLYS · Traditional Biodynamic Technologies, Inc.05/02/1986SE
K860016Aesculap Bone MillLYS · Traditional Aesculap Instruments Corp.03/19/1986SE

More from Aesculap Instruments Corp.

510(k)DeviceDecision
K884407Tracer Skeletal Traction PinsHSB · Traditional 11/28/1988SE
K884406Tracer Hip Pinning SystemJDS · Traditional 11/28/1988SE

Questions and answers

When was Tracer Bone Mill cleared by the FDA?

Tracer Bone Mill (K883183) received a 510(k) decision of Substantially Equivalent on October 12, 1988, 76 days after the submission was received.

What is the product code of K883183?

The FDA product code is LYS – Bone Mill, a Class I (low risk) device regulated under 21 CFR 888.4540.