ClearanceBrief
510(k) K080802 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)

EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL

ApplicantThe Anspach Effort, Inc., Palm Beach Gardens FL, US
DecisionSubstantially Equivalent, Apr 30, 2008
ReceivedMar 21, 2008
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K080802

DateFirm and productCodeLinked 510(k)
Oct 6, 2016The Anspach Effort, Inc.
Electronic Foot Control with Direction Switch Product Usage: Electric system
Terminated		 GEYNone listed
Oct 6, 2016The Anspach Effort, Inc.
Electronic Foot Control with Direction or Irrigation Switches Product Usage: Electric system
Terminated		 GEYNone listed
Oct 6, 2016The Anspach Effort, Inc.
eMax2 PLUS Product Usage: Electric system
Terminated		 HBCNone listed
Oct 6, 2016The Anspach Effort, Inc.
Console, eMax2 Plus Product Usage: Electric system
Terminated		 GEYNone listed
Oct 6, 2016The Anspach Effort, Inc.
System Console, Single Port, with irrigation Product Usage: Electric system
Terminated		 GEYNone listed
Oct 6, 2016The Anspach Effort, Inc.
System Console, Single Port, no irrigation
Terminated		 GETNone listed
Oct 6, 2016The Anspach Effort, Inc.
12.4cm Heavy Duty Long Heavy Short Attachment Product Usage: Pneumatic system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
Sagittal Saw Product Usage: Pneumatic system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
Oscillating MICRO-SAW Product Usage: Pneumatic system
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
Reciprocating MICRO SAW
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
Sagittal MICRO-SAW
Terminated		 BWNNone listed
Oct 6, 2016The Anspach Effort, Inc.
20.2cm Heavy Duty Long Heavy Short Attachment
Terminated		 BWNNone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBENone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBENone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBENone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBENone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBENone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBENone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBENone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBENone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBENone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBENone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBENone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBENone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBENone listed
Jun 25, 2014The Anspach Effort, Inc.
ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered Tip***Rx Only*** This device is intended to be used with Anspach Systems
Terminated		 HBENone listed
Jan 13, 2014The Anspach Effort, Inc.
Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8
Terminated		 HBENone listed
Jan 13, 2014The Anspach Effort, Inc.
Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball p
Terminated		 HBENone listed
Jan 13, 2014The Anspach Effort, Inc.
Anspach Carbide Cutting Burrs & Drums: 1.5MM x 7.5MM Cylindrical Carbide Drum part # S-15DRMC Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
Terminated		 HBENone listed
Jan 13, 2014The Anspach Effort, Inc.
Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and shaping bone, inclu
Terminated		 HBENone listed
Nov 13, 2013The Anspach Effort, Inc.
Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, al
Terminated		 HBENone 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
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

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