Osteomill Bone Grinder

FDA 510(k) K861164 · Biodynamic Technologies, Inc.

Substantially Equivalent

510(k) numberK861164

Submission

Device name
Osteomill Bone Grinder
Applicant
Biodynamic Technologies, Inc.
Arlington, VA, US
Received
March 28, 1986
Decision date
May 2, 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
K860016Aesculap Bone MillLYS · Traditional Aesculap Instruments Corp.03/19/1986SE

More from Aesculap Instruments Corp.

510(k)DeviceDecision
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K990481Ultimax Distal Radial (Volar) Locking Plate SystemHRS · Traditional 03/17/1999SE
K981230Ultimax Distal Femoral Intramedullary Rod SystemHSB · Traditional 06/01/1998SE
K980102Bti Humeral Intramedullary Rod SystemHSB · Traditional 04/03/1998SE
K974756Bti Large (7.0MM) Cannulated Transfixing ScrewsHWC · Traditional 03/12/1998SN
K972403Bti Cortical Bone ScrewsHWC · Traditional 08/29/1997SE
K970897Bti Distal Femoral Intramedullary Rod SystemHSB · Traditional 04/21/1997SE
K962706Ez-Fix Cannulated Screw SystemHWC · Traditional 11/13/1996SE
K962987Ez-Fix Small Cannulated Screw SystemHWC · Traditional 11/04/1996SE

Questions and answers

When was Osteomill Bone Grinder cleared by the FDA?

Osteomill Bone Grinder (K861164) received a 510(k) decision of Substantially Equivalent on May 2, 1986, 35 days after the submission was received.

What is the product code of K861164?

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