Atlas FDA

ANSPACH EMAX DRILL SYSTEM

FDA 510(k) clearance K011444 · decided 2001-08-08

Clearance details

K-number
K011444
Device name
ANSPACH EMAX DRILL SYSTEM
Applicant
The Anspach Effort, Inc.
Decision
Substantially Equivalent
Date received
2001-05-11
Decision date
2001-08-08
Days to decision
89 days
Clearance type
Traditional
Product code
HBC
Device class
2
Regulation number
882.4360
Medical specialty
Neurology
Advisory committee
Neurology
Location
Palm Beach Gardens, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems. Re recall (Z-0916-2023)The Anspach Effort, Inc.2023-01-07
6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Sys recall (Z-0917-2023)The Anspach Effort, Inc.2023-01-07
Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine recall (Z-0918-2023)The Anspach Effort, Inc.2023-01-07
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref recall (Z-0919-2023)The Anspach Effort, Inc.2023-01-07
7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref: CRANI-L recall (Z-0920-2023)The Anspach Effort, Inc.2023-01-07
Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including th recall (Z-0921-2023)The Anspach Effort, Inc.2023-01-07
7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref recall (Z-0922-2023)The Anspach Effort, Inc.2023-01-07
6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRA recall (Z-0923-2023)The Anspach Effort, Inc.2023-01-07
Pediatric Craniotome Ref:CRANI-P-G1 recall (Z-0924-2023)The Anspach Effort, Inc.2023-01-07
ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx Only recall (Z-1895-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This dev recall (Z-1896-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a Speed recall (Z-1899-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** This device is recall (Z-1904-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***R recall (Z-1905-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is i recall (Z-1908-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*** This devic recall (Z-1909-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx recall (Z-1910-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx recall (Z-1911-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx recall (Z-1912-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only*** recall (Z-1913-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This devi recall (Z-1917-2014)The Anspach Effort, Inc.2014-06-25
ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachmen recall (Z-1574-2014)The Anspach Effort, Inc.2014-05-09
AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm scr recall (Z-0829-2014)The Anspach Effort, Inc.2014-01-27
Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone recall (Z-0830-2014)The Anspach Effort, Inc.2014-01-27
Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intende recall (Z-0779-2014)The Anspach Effort, Inc.2014-01-16
Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Moto recall (Z-0198-2014)The Anspach Effort, Inc.2013-11-13
"***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone i recall (Z-0074-2013)The Anspach Effort, Inc.2012-10-18
"***Electric Systems Foot Control with Direction Only***Rx Only***" Product Usage: Cutting recall (Z-0075-2013)The Anspach Effort, Inc.2012-10-18
"***Electric Systems Foot Control with Direction and Irrigation***Rx Only***" Product Usag recall (Z-0076-2013)The Anspach Effort, Inc.2012-10-18
Cutting Burr labeled in part:"***S-1504TD QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use recall (Z-3202-2011)The Anspach Effort, Inc.2011-09-14
Cutting Burr labeled in part:"***TURQ-434-4 QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. U recall (Z-3203-2011)The Anspach Effort, Inc.2011-09-14
Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in part:***IMRI-S-8NS-M***QTY: 1***3 recall (Z-3189-2011)The Anspach Effort, Inc.2011-09-13
Sterile Bone Cutting Burrs model M-6P labeled in part:***M-6P***QTY: 1***6 mm x 9 mm Flute recall (Z-3190-2011)The Anspach Effort, Inc.2011-09-13
Sterile Bone Cutting Burrs model QD8-4OVD labeled in part:***QD8-4OVD***QTY: 1***4 mm x 8 recall (Z-3191-2011)The Anspach Effort, Inc.2011-09-13
Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills, burrs, trep recall (Z-0083-2010)The Anspach Effort, Inc.2009-10-28
Anspach Single Use, Sterile Bone Cutting Burrs recall (Z-1008-2007)The Anspach Effort, Inc.2007-07-11
Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does recall (Z-1243-03)The Anspach Effort, Inc.2003-10-15