Device
Instrument
Manufacturer
MAKO SURGICAL CORP.
Model: 290651 Catalog: 290651 DI: 07613327595543 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-05-21 Current Version: 2026-05-29
Description
Instrument
Sterilization
Method Types - Sterilization Method: Moist Heat or Steam Sterilization
Device Sterile: No
Sterilization Prior To Use: Yes
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 4b7a0f31-0bcb-4f6e-971e-217b63a06e3a
Distribution Status: In Commercial Distribution
DUNS Number: 175239677
Device Count: 1
DM Exempt: No
Premarket Exempt: No
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: Yes
Serial Number Tracked: No
Manufacturing Date Tracked: No
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 07613327595543
Type: Primary
Issuing Agency: GS1
GMDN
Code: 43555
Name: Burring power tool attachment
Definition:
A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.
FDA Product Codes
OLO
Orthopedic stereotaxic instrument