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Panels › General, Plastic Surgery › Product code HSZ · Class 1

Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment

Regulation 878.4820

0510(k)s in 12 months (56 all time)

0recalls in 12 months (6 all time)

4recalls that name a 510(k)

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Top companies in HSZ

Company	510(k)s	Recalls
The Anspach Effort, Inc.	4	4
Micro-Aire Surgical Instruments, Inc.	8	0
American Sterilizer Co.	3	0
Micro Surgical Instruments Corp.	3	0
Tava Surgical Instruments	3	0
Acufex Microsurgical, Inc.	2	0
Anspach Mfg., Inc.	2	0
De Soutter Medical, Ltd.	2	0
Romano Surgical Instrumentation, Inc.	2	0
Smith & Nephew Richards, Inc.	2	0

Date	Firm and product	Code	Linked 510(k)
Mar 1, 2024	Synthes (USA) Products LLC 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S Open, Classified	HSZ	None listed
Mar 1, 2024	Synthes (USA) Products LLC 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S Open, Classified	HSZ	None listed
Oct 6, 2016	The Anspach Effort, Inc. BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system Terminated	HSZ	K955084
Jul 3, 2014	The Anspach Effort, Inc. Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium. Terminated	HSZ	K955084
Jan 9, 2014	The Anspach Effort, Inc. *REF BLACKMAX-NSwivel/Angle Motor AssemblyRx Only*The Anspach Effort, Inc. Intended for cutting and shaping bone. Terminated	HSZ	K955084
Nov 13, 2013	The Anspach Effort, Inc. Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, Terminated	HSZ	K955084

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