ClearanceBrief
510(k) K011444 ยท HBC Motor, Drill, Electric

ANSPACH EMAX DRILL SYSTEM

ApplicantThe Anspach Effort, Inc., Palm Beach Gardens FL, US
DecisionSubstantially Equivalent, Aug 8, 2001
ReceivedMay 11, 2001
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K011444

DateFirm and productCodeLinked 510(k)
Jan 7, 2023The Anspach Effort, Inc.
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
Open, Classified		 HBCNone listed
Jan 7, 2023The Anspach Effort, Inc.
6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medica
Open, Classified		 HBCNone listed
Jan 7, 2023The Anspach Effort, Inc.
Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
Open, Classified		 HBCNone listed
Jan 7, 2023The Anspach Effort, Inc.
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
Open, Classified		 HBCNone listed
Jan 7, 2023The Anspach Effort, Inc.
7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
Open, Classified		 HBCNone listed
Jan 7, 2023The Anspach Effort, Inc.
Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
Open, Classified		 HBCNone listed
Jan 7, 2023The Anspach Effort, Inc.
7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
Open, Classified		 HBCNone listed
Jan 7, 2023The Anspach Effort, Inc.
6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
Open, Classified		 HBCNone listed
Jan 7, 2023The Anspach Effort, Inc.
Pediatric Craniotome Ref:CRANI-P-G1
Open, Classified		 HBCNone listed
Oct 6, 2016The Anspach Effort, Inc.
14cm QD Angle Attachment Product Usage: Product attachment
Terminated		 HBCNone listed
Oct 6, 2016The Anspach Effort, Inc.
AL-III W/ male disconnect and 20ft hose Product Usage: Pneumatic system
Terminated		 GEYNone listed
Oct 6, 2016The Anspach Effort, Inc.
AL-III W/ male disconnect and 30ft hose Product Usage: Pneumatic system
Terminated		 GEYNone listed
Oct 6, 2016The Anspach Effort, Inc.
Foot control irrigation system Product Usage: Pneumatic system
Terminated		 GEYNone listed
Oct 6, 2016The Anspach Effort, Inc.
Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
Terminated		 ERLNone listed
Oct 6, 2016The Anspach Effort, Inc.
Electric Handpiece EM Hand Control Product Usage: Electric system
Terminated		 HBCNone listed
Oct 6, 2016The Anspach Effort, Inc.
eMax2 Motor Assembly Product Usage: Electric system
Terminated		 HBCNone listed
Oct 6, 2016The Anspach Effort, Inc.
eMax2 Hybrid Hand Control Product Usage: Electric system
Terminated		 HBCNone listed
Oct 6, 2016The Anspach Effort, Inc.
Foot Control, SC2100 Product Usage: Electric system
Terminated		 ERLNone listed
Oct 6, 2016The Anspach Effort, Inc.
Foot Control without Switches, SC2100 Product Usage: Electric system
Terminated		 ERLNone listed
Oct 6, 2016The Anspach Effort, Inc.
7.2cm Adjustable Drill Guide Product Usage: Electric system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
6.8cm Controlled Depth Attachment Product Usage: Pneumatic system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
Adult Craniotome Product Usage: Pneumatic system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
6.5CM ADLT CRANI, THIN FT PLATE Product Usage: Pneumatic system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
Rotating Adult Craniotome Product Usage: Pneumatic system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
Rotating Large Craniotome
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
Pediatric Craniotome
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
Chuck Driver System
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
11.0cm Long Attachment Product Usage: Pneumatic system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
10.5cm Long Attachment, Non-Tapered End Product Usage: Pneumatic system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
10.5cm Long Attachment Product Usage: Pneumatic system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
8.0cm Medium Attachment Product Usage: Pneumatic system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
8.0CM Heavy Duty Medium Attachment Product Usage: Pneumatic system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
16cm Minimally Invasive Attachment Product Usage: Pneumatic system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
11cm QD Angle Attachment Product Usage: Pneumatic system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
14cm QD Angle Attachment Product Usage: Pneumatic system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
14cm QD Angle Attachment
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
8cm QD Angle Attachment
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
7.5cm QD Angle Attachment
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
SMALL ATTACHMENT, JACOBS CHUCK
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
SMALL ATTACHMENT, J-LATCH
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
5.0cm Short Attachment
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
5.0cm Heavy Duty Short Attachment
Terminated		 BWNNone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBCNone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBCNone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a Speed Reducer***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBCNone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBCNone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBCNone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBCNone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBCNone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBCNone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBCNone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBCNone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBCNone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBCNone listed
May 9, 2014The Anspach Effort, Inc.
ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
Terminated		 HTTNone listed
Jan 27, 2014The Anspach Effort, Inc.
AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
Terminated		 HBCNone listed
Jan 27, 2014The Anspach Effort, Inc.
Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
Terminated		 GFFNone listed
Jan 16, 2014The Anspach Effort, Inc.
Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.
Terminated		 ERLNone listed
Nov 13, 2013The Anspach Effort, Inc.
Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the Pneumatic Motor Systems including: BlackMax Motor Systems, MicroMax Systems and XMax Motor Systems all models and serial num
Terminated		 HBCNone listed
Oct 18, 2012The Anspach Effort, Inc.
"***Electric Systems Foot Control****Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Terminated		 HBENone listed
Oct 18, 2012The Anspach Effort, Inc.
"***Electric Systems Foot Control with Direction Only***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Terminated		 HBENone listed
Oct 18, 2012The Anspach Effort, Inc.
"***Electric Systems Foot Control with Direction and Irrigation***Rx Only***" Product Usage: Cutting and shaping bone including bones of the spine and cranium.
Terminated		 HBENone listed
Sep 14, 2011The Anspach Effort, Inc.
Cutting Burr labeled in part:"***S-1504TD QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with SHORT Attachments.***ANSPACH***Manufacturer Made in USA***The Anspach Effort, Inc***4500 Riverside Driv
Terminated		 HBCNone listed
Sep 14, 2011The Anspach Effort, Inc.
Cutting Burr labeled in part:"***TURQ-434-4 QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with B-TURQUOISE Attachment.***ANSPACH***Manufacturer Made in USA***The Anspach Effort, Inc***4500 Riversi
Terminated		 HBCNone listed
Sep 13, 2011The Anspach Effort, Inc.
Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in part:***IMRI-S-8NS-M***QTY: 1***3 mm Fluted Matchstick, Extends 8.9 mm,***Less Aggressive. Use with IMRI-SHORT***Attachments.***Use by 2014 08*
Terminated		 HBCNone listed
Sep 13, 2011The Anspach Effort, Inc.
Sterile Bone Cutting Burrs model M-6P labeled in part:***M-6P***QTY: 1***6 mm x 9 mm Fluted Pear.***Use with*** MEDIUM Attachments.***Use by 2015-12***ANSPACH***Manufacturer***Made in USA***The Anspa
Terminated		 HBCNone listed
Sep 13, 2011The Anspach Effort, Inc.
Sterile Bone Cutting Burrs model QD8-4OVD labeled in part:***QD8-4OVD***QTY: 1***4 mm x 8 mm Diamond Oval. Use with***QD8 Attachments.***Use by 2016-03***ANSPACH***Manufacturer***Made in USA***The A
Terminated		 HBCNone listed
Oct 28, 2009The Anspach Effort, Inc.
Foot Pedal, Foot Control for SC2000 and SC2100 Powered, simple cranial drills, burrs, trephines, and their accessories. Catalog Numbers: EMAX2-FP and FPLUS-FP. Indicated to cut and shape bone includ
Terminated		 HBENone listed
Jul 11, 2007The Anspach Effort, Inc.
Anspach Single Use, Sterile Bone Cutting Burrs
Terminated		 HBBNone listed
Oct 15, 2003The Anspach Effort, Inc.
Product is Anspach eMax Drill System console, catalog numbers SC-1000 and SC-1000-1 (does not include the related drill motor, foot-pedal control, motor attachments or drills/burrs)
Terminated		 HBCNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.