Atlas FDA

ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]

FDA 510(k) clearance K081475 · decided 2008-10-17

Clearance details

K-number
K081475
Device name
ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]
Applicant
Medtronic Xomed, Inc.
Decision
Substantially Equivalent
Date received
2008-05-27
Decision date
2008-10-17
Days to decision
143 days
Clearance type
Traditional
Product code
HBE
Device class
2
Regulation number
882.4310
Medical specialty
Neurology
Advisory committee
Neurology
Location
Jacksonville, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

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PMA approvals by this applicant

RecordFirmDate
LAMICEL OSMOTIC CERVICAL DILATOR (P820075/S009)Medtronic Xomed, Inc.1999-07-16
LAMICEL OSMOTIC CERVICAL DILATOR (P820075/S008)Medtronic Xomed, Inc.1999-07-09
LAMICEL(R) OSMOSTIC CERVICAL DILATOR (P820075/S007)Medtronic Xomed, Inc.1996-01-03
LAMICEL(R) OSSMOTIC CERVICAL DILATOR (P820075/S006)Medtronic Xomed, Inc.1995-10-10
LAMICEL(R) OSSMOTIC CERVICAL DILATOR (P820075/S005)Medtronic Xomed, Inc.1991-10-09
LAMICEL(TM) (P820075/S004)Medtronic Xomed, Inc.1988-05-24
LAMICEL(TM) (P820075/S002)Medtronic Xomed, Inc.1986-08-22
LAMICEL(TM) (P820075/S001)Medtronic Xomed, Inc.1985-02-12