Aesculap Bone Mill

FDA 510(k) K860016 · Aesculap Instruments Corp.

Substantially Equivalent

510(k) numberK860016

Submission

Device name
Aesculap Bone Mill
Applicant
Aesculap Instruments Corp.
Burlingame, CA, US
Received
January 3, 1986
Decision date
March 19, 1986
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
K883183Tracer Bone MillLYS · Traditional De Medica Mfg., Inc.10/12/1988SE
K860356Orthoblend Powered Bone MillLYS · Traditional Zimmer, Inc.07/08/1986SE
K861164Osteomill Bone GrinderLYS · Traditional Biodynamic Technologies, Inc.05/02/1986SE

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Questions and answers

When was Aesculap Bone Mill cleared by the FDA?

Aesculap Bone Mill (K860016) received a 510(k) decision of Substantially Equivalent on March 19, 1986, 75 days after the submission was received.

What is the product code of K860016?

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