Panels › Orthopedic › Product code HTT · Class 1

Burr, Orthopedic

Regulation 888.4540

0510(k)s in 12 months (4 all time)

0recalls in 12 months (23 all time)

14recalls that name a 510(k)

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Top companies in HTT

Company	510(k)s	Recalls
The Anspach Effort, Inc.	1	21
Cutter Laboratories, Inc.	1	0
Hall Surgical, Division of Zimmer, Inc.	1	0
Linvatec Corp. dba ConMed Linvatec	0	1
Micro-Aire Surgical Instruments, Inc.	1	0
Zimmer Gmbh	0	1

Date	Firm and product	Code	Linked 510(k)
May 15, 2017	Zimmer Gmbh Normed General Instruments 503004541: Werber Countersink Cannulated for micro CBS Screws, AO 503004341: Werber Countersink Cannulated for micro CBS Screws, round-shaft The Countersink is an instrument Terminated	HTT	None listed
May 9, 2014	The 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	HTT	K011444
Feb 4, 2013	The Anspach Effort, Inc. Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures. Terminated	HTT	None listed
Oct 21, 2011	The Anspach Effort, Inc. "*REF S-6AC6 mm Fluted Acorn. Use with SHORT Attachments. ANSPACHSterile, Sterilized using IrradiationRx OnlyMade in the USA**Manufacturer: The Anspach Effort, Inc. 4500 Riverside D Terminated	HTT	K802598
Oct 21, 2011	The Anspach Effort, Inc. "*REF S-35DC3.5 mm Coarse Diamond Ball, Extended Length. Use with SHORT Attachments.ANSPACHSterile, Sterilized using IrradiationRx OnlyMade in the USA**Manufacturer: The Anspach Eff Terminated	HTT	K802598
Oct 21, 2011	The Anspach Effort, Inc. "*REF A-CRN1.85 mm x 16 mm Fluted Router. Use with CRANI-A Attachments.ANSPACHSterile, Sterilized using IrradiationRx Only Made in the USA**Manufacturer: The Anspach Effort, Inc. Terminated	HTT	K802598
Oct 21, 2011	The Anspach Effort, Inc. "*REF L-CRN2.5 mm x 25.4 mm Fluted Router. Use with CRANI-L Attachments.ANSPACHSterile, Sterilized using IrradiationRx Only Made in the USA**Manufacturer: The Anspach Effort, Inc Terminated	HTT	K802598
Oct 21, 2011	The Anspach Effort, Inc. "*REF TURQ-L55 mm Fluted Ball. Use with B-TURQ-L Attachment. ANSPACHSterile, Sterilized using IrradiationRx OnlyMade in the USA**Manufacturer: The Anspach Effort, Inc. 4500 Rivers Terminated	HTT	K802598
Oct 21, 2011	The Anspach Effort, Inc. '*REF SIL-3-101.93 mm Suture Pass Drill/ 1.17 eye. Use with B-SILVER Attachment.ANSPACHSterile, Sterilized using IrradiationRx Only Made in the USA**Manufacturer: The Anspach Effort Terminated	HTT	K802598
Oct 21, 2011	The Anspach Effort, Inc. "*REF LHD-6B-M6 mm Fluted Ball. Use with LONG-HD Attachment. ANSPACHSterile, Sterilized using IrradiationRx OnlyMade in the USA**Manufacturer: The Anspach Effort, Inc. 4500 Riversid Terminated	HTT	K802598
Oct 21, 2011	The Anspach Effort, Inc. "*REF GRE-11.85 mm x 16 mm Fluted Router. Use with B-GREEN Attachments.ANSPACHSterile, Sterilized using IrradiationRx Only Made in the USA**Manufacturer: The Anspach Effort, Inc. 45 Terminated	HTT	K802598
Oct 21, 2011	The Anspach Effort, Inc. "*REF BLU-LS9-5E4.7 mm x 20 mm Fluted Drum, Side Cut Only. Use with B-BLUE-S Attachment. ANSPACHSterile, Sterilized using IrradiationRx Only Made in the USA**Manufacturer: The Anspa Terminated	HTT	K802598
Oct 21, 2011	The Anspach Effort, Inc. "*REF BLU-395 mm Fluted Acorn. Use with B-BLUE-S Attachment. ANSPACHSterile, Sterilized using IrradiationRx OnlyMade in the USA**Manufacturer: The Anspach Effort, Inc. 4500 Riversid Terminated	HTT	K802598
Oct 21, 2011	The Anspach Effort, Inc. "*REF BLU-55 mm Fluted Ball. Use with B-BLUE-S Attachment. ANSPACHSterile, Sterilized using IrradiationRx OnlyMade in the USA**Manufacturer: The Anspach Effort, Inc. 4500 Riverside Terminated	HTT	K802598
Oct 21, 2011	The Anspach Effort, Inc. "*REF QD8-5B5 mm Fluted Ball. Use with QD8 Attachments. ANSPACHSterile, Sterilized using IrradiationRx OnlyMade in the USA**Manufacturer: The Anspach Effort, Inc. 4500 Riverside Dri Terminated	HTT	K802598
Oct 21, 2011	The Anspach Effort, Inc. "*REF QD11-6B6 mm Fluted Ball. Use with QD11 Attachments. ANSPACHSterile, Sterilized using IrradiationRx OnlyMade in the USA**Manufacturer: The Anspach Effort, Inc. 4500 Riverside D Terminated	HTT	K802598
Apr 20, 2011	The Anspach Effort, Inc. *REF MCA7-2SB2 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).ANSPACHSterile, Sterilized using IrradiationRx Only Made in the USA**Manufacturer: The Anspach Effort, Terminated	HTT	None listed
Apr 20, 2011	The Anspach Effort, Inc. *REF MCA7-1SB* 1 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment (MCA).*ANSPACHSterile, Sterilized using IrradiationRx OnlyMade in the USA**Manufacturer: The Anspach Effort, Terminated	HTT	None listed
Apr 20, 2011	The Anspach Effort, Inc. *REF MCA7-15SB* 1.5 mm Fluted Ball, 7.3 cm. Use with Micro Curved Attachment.*ANSPACHSterile, Sterilized using IrradiationRx Only* Made in the USA***Manufacturer: The Anspach Effort, In Terminated	HTT	None listed
Apr 20, 2011	The Anspach Effort, Inc. *REF MCA5-2SB* 2 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).*ANSPACHSterile, Sterilized using IrradiationRx Only* Made in the USA***Manufacturer: The Anspach Effort, Terminated	HTT	None listed
Apr 20, 2011	The Anspach Effort, Inc. *REF MCA5-15SB 1.5 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).ANSPACHSterile, Sterilized using IrradiationRx Only* Made in the USA***Manufacturer: The Anspach Eff Terminated	HTT	None listed
Apr 20, 2011	The Anspach Effort, Inc. REF MCA5-1SB* 1 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA). *ANSPACHSterile. Sterilized using IrradiationRx Only.Made in the USA**Manufacturer: The Anspach Effort, Terminated	HTT	None listed
Sep 8, 2009	Linvatec Corp. dba ConMed Linvatec ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number 00702109200, STERILE, Single-use. Made is USA. ST ULTRAPOWER Diamond Wheel/MDS M-51, (MUSTARD) 25.4 mm For Use with Low or Medium Speed Dril Terminated	HTT	None listed

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