ClearanceBrief
Panels › Neurology › Product code HBC · Class 2

Motor, Drill, Electric

Regulation 882.4360

1510(k)s in 12 months (27 all time)
0recalls in 12 months (39 all time)
37recalls that name a 510(k)
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Top companies in HBC

Company510(k)sRecalls
The Anspach Effort, Inc.338
Aesculap, Inc.31
Medtronic Powered Surgical Solutions30
Bien-Air Surgery SA20
Linvatec Corp.20
Nakanishi, Inc.20
Saeshin Precision Co., Ltd.20
Sodemsystems20
Bioplate, Inc.10
Black & Decker(Tm)10
DateFirm and productCodeLinked 510(k)
Jan 7, 2023The Anspach Effort, Inc.
Pediatric Craniotome Ref:CRANI-P-G1
Open, Classified		 HBCK011444
K133604
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		 HBCK011444
K133604
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		 HBCK011444
K133604
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		 HBCK011444
K133604
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		 HBCK011444
K133604
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		 HBCK011444
K133604
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		 HBCK011444
K133604
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		 HBCK011444
K133604
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		 HBCK011444
K133604
Oct 6, 2016The Anspach Effort, Inc.
eMax2 PLUS Product Usage: Electric system
Terminated		 HBCK080802
Oct 6, 2016The Anspach Effort, Inc.
eMax2 Hybrid Hand Control Product Usage: Electric system
Terminated		 HBCK011444
Oct 6, 2016The Anspach Effort, Inc.
eMax2 Motor Assembly Product Usage: Electric system
Terminated		 HBCK011444
Oct 6, 2016The Anspach Effort, Inc.
Electric Handpiece EM Hand Control Product Usage: Electric system
Terminated		 HBCK011444
Oct 6, 2016The Anspach Effort, Inc.
14cm QD Angle Attachment Product Usage: Product attachment
Terminated		 HBCK011444
Jun 15, 2016The Anspach Effort, Inc.
Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A) Use for cutting and shaping bone including bones of the cranium and spine.
Terminated		 HBCK133604
Feb 2, 2015The Anspach Effort, Inc.
16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1
Terminated		 HBCK133604
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		 HBCK011444
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		 HBCK011444
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		 HBCK011444
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		 HBCK011444
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		 HBCK011444
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		 HBCK011444
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		 HBCK011444
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		 HBCK011444
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		 HBCK011444
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		 HBCK011444
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		 HBCK011444
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		 HBCK011444
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		 HBCK011444
K974025
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		 HBCK011444
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		 HBCK011444
K974025
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		 HBCK011444
K974025
Sep 13, 2011The Anspach Effort, Inc.
Sterile Bone Cutting Burrs model SIL-7-9 labeled in part:***SIL-7-9***QTY: 1***9 mm Fluted Ball.***Use with B-Silber***Attachment.***Use by 2015-01***ANSPACH***Manufacturer***Made in USA***The Anspach
Terminated		 HBCNone listed
Sep 13, 2011The Anspach Effort, Inc.
Sterile Bone Cutting Burrs model S-5B-4 labeled in part:***S-5B-4***QTY: 1***5 mm Fluted Ball, 4-Series.***Use with***SHORT Attachments.***Use by 2016-03***ANSPACH***Manufacturer***Made in USA***The A
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		 HBCK011444
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		 HBCK011444
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		 HBCK011444
Mar 2, 2011Aesculap Inc
Aesculap MicroSpeed Uni Control Box, Part #GD670 Intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro and Maxillo facial Surger
Terminated		 HBCK053526
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		 HBCK011444

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