Panels › General, Plastic Surgery › Product code HWE · Class 1
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Regulation 878.4820
0510(k)s in 12 months (76 all time)
0recalls in 12 months (101 all time)
14recalls that name a 510(k)
Top companies in HWE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2017 | Zimmer Biomet, Inc. M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic surgical instrument. Terminated |
HWE | None listed |
| Sep 22, 2017 | Zimmer Biomet, Inc. NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 3.5 mm Diameter 195 mm Length, Item Number/EDI 0200024325, Nonsterile. orthopedic surgical instrument. Terminated |
HWE | None listed |
| Sep 22, 2017 | Zimmer Biomet, Inc. Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 00480606011, Nonsterile. orthopedic surgical instrument. Terminated |
HWE | None listed |
| Sep 22, 2017 | Zimmer Biomet, Inc. Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 00480507015, Nonsterile. orthopedic surgical instrument. Terminated |
HWE | None listed |
| Sep 22, 2017 | Zimmer Biomet, Inc. Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443, Nonsterile. orthopedic surgical instrument. Terminated |
HWE | None listed |
| Sep 22, 2017 | Zimmer Biomet, Inc. ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile. orthopedic surgical instrument. Terminated |
HWE | None listed |
| Sep 22, 2017 | Zimmer Biomet, Inc. Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter, Item Number/EDI 00236015327, Nonsterile. orthopedic surgical instrument. Terminated |
HWE | None listed |
| Sep 22, 2017 | Zimmer Biomet, Inc. ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile. orthopedic surgical instrument. Terminated |
HWE | None listed |
| Sep 22, 2017 | Zimmer Biomet, Inc. M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32, Item Number/EDI 00225503137, Nonsterile. orthopedic surgical instrument. Terminated |
HWE | None listed |
| Sep 22, 2017 | Zimmer Biomet, Inc. Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/EDI 00129100400, Nonsterile. orthopedic surgical instrument. Terminated |
HWE | None listed |
| Sep 22, 2017 | Zimmer Biomet, Inc. Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile Terminated |
HWE | None listed |
| Feb 28, 2017 | Stryker Instruments Div. of Stryker Corporation Stryker SmartLife Large Aseptic Housing (7126-120-000) Terminated |
HWE | None listed |
| Dec 1, 2016 | Synthes (USA) Products LLC Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm
Non-Sterile Terminated |
HWE | K043310 |
| Oct 18, 2016 | Stryker Instruments Div. of Stryker Corporation Sagittal Blade 18.0X0.97X90MM, Model Number: 6118-097-090
Product Usage:
Heavy duty Sagittal Blades are used to cut bone and bone related tissue in a variety of orthopedic procedures. Typical procedu Terminated |
HWE | None listed |
| Sep 27, 2016 | The Anspach Effort, Inc. Adaptor for Small Battery Drive and Small Battery Drive II.
Product Usage:
The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and ort Terminated |
HWE | K043310 |
| Sep 27, 2016 | The Anspach Effort, Inc. Light Adaptor for Small Battery Drive and Small Battery Drive II. Terminated |
HWE | K043310 |
| Jul 12, 2016 | Synthes (USA) Products LLC Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001
Product Usage:
The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist wit Terminated |
HWE | K043310 |
| Jul 12, 2016 | Synthes (USA) Products LLC Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002
Product Usage:
The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to Terminated |
HWE | None listed |
| Jul 12, 2016 | Synthes (USA) Products LLC Part #313.231, 2.0mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341036, 4363819, 4427699, mfg. 3/4/2002-6/6/2002
Product Usage:
The DePuy Synthes MR Safe Instruments and MR conditiona Terminated |
HWE | None listed |
| Jul 12, 2016 | Synthes (USA) Products LLC Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. Terminated |
HWE | None listed |
| Jul 12, 2016 | Synthes (USA) Products LLC Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002
Product Usage:
The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to Terminated |
HWE | None listed |
| Jul 12, 2016 | Synthes (USA) Products LLC Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002
Product Usage:
The DePuy Synthes MR Safe Instruments and MR conditio Terminated |
HWE | None listed |
| Jul 12, 2016 | Synthes (USA) Products LLC Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098
Product Usage:
The DePuy Synthes MR Safe Instruments and MR conditional Instruments are u Terminated |
HWE | None listed |
| Jul 12, 2016 | Synthes (USA) Products LLC Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007
Product Usage:
The DePuy Synthes MR Safe Instruments and MR conditional Instr Terminated |
HWE | None listed |
| Jul 12, 2016 | Synthes (USA) Products LLC Part # SD313.011, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Short, Lot # UR75220, mfg 7/18/2007
Product Usage:
The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to Terminated |
HWE | None listed |
| Jul 12, 2016 | Synthes (USA) Products LLC Part # 313.946, Low Profile Neuro Screwdriver Blade/MR Safe/MQC/56mm Medium, Lot # 5053374, mfg 7/27/2005
Product Usage:
The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used Terminated |
HWE | None listed |
| Jul 12, 2016 | Synthes (USA) Products LLC Screwdriver Blade, Handle, Drill Bit,
Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859
Product Usage:
The DePuy Synthes MR Safe Instruments and MR conditional In Terminated |
HWE | None listed |
| Apr 26, 2016 | Greatbatch Medical Torque Limiting Adapter:
Torque Limiting Attachment, Non Sterile, Distributed by Zimmer.
PRECIMED, Torque Limiting Adaptor, Non Sterile..
Customer Number/Model:
00-2360-080-00 T10232, T116245 T Terminated |
HWE | None listed |
| Apr 26, 2016 | Greatbatch Medical Torque Limiting Handle:
PRECIMED, T-Handle Torque, Non Sterile.
Handle:
Customer Number/Model:
MCL120014 T14000, TLT911-50-S20 TLT911-50-S20,
TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 T Terminated |
HWE | None listed |
| Oct 22, 2015 | Smith & Nephew, Inc., Endoscopy Div. Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 8.5 mm, Sterile
Part Number: 7209237
Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra Terminated |
HWE | K964215 |
| Oct 22, 2015 | Smith & Nephew, Inc., Endoscopy Div. Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 6.5 mm, Sterile
Part Number: 7209236
Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra Terminated |
HWE | K964215 |
| Oct 22, 2015 | Smith & Nephew, Inc., Endoscopy Div. Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile
Part Number: 7209235
Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra Terminated |
HWE | K964215 |
| Oct 22, 2015 | Smith & Nephew, Inc., Endoscopy Div. Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 3.5 mm, Sterile
Part Number: 7209234
Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondra Terminated |
HWE | K964215 |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange X-SAW BLADE;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number 5059-531;
EXP (repackager), Linvatic Corp (OEM)
Instrument, surgical, orthopedic, ac-powered
mot Terminated |
HWE | None listed |
| May 7, 2015 | Stryker Instruments Div. of Stryker Corporation Universal Charger
Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal B Terminated |
HWE | None listed |
| Apr 30, 2015 | The Anspach Effort, Inc. Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery. Terminated |
HWE | None listed |
| Mar 23, 2015 | Synthes, Inc. Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smo Terminated |
HWE | K043310 |
| Feb 9, 2015 | Stryker Instruments Div. of Stryker Corporation System 6 Aseptic Housing.
The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument. Terminated |
HWE | None listed |
| Jan 12, 2015 | Medtronic Sofamor Danek USA Inc POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc. Spinal surgical instrumrent. Terminated |
HWE | K111520 |
| Nov 5, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker SmartLife Small Aseptic Housing
REF 7222-120-000
Rx Only
The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for S Terminated |
HWE | None listed |
| Nov 5, 2014 | Stryker Instruments Div. of Stryker Corporation Stryker SmartLife Large Aseptic Housing
REF 7126-120-000
Rx Only
The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for S Terminated |
HWE | None listed |
| Dec 31, 2013 | Synthes USA HQ, Inc. Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012
The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decort Terminated |
HWE | K043310 |
| Dec 2, 2011 | Synthes USA (HQ), Inc. Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive.
This surgical instrument motor and accessories are AC-powered, battery-powered or air-powered devices intended for use during s Terminated |
HWE | None listed |
| Jul 25, 2011 | W & H DentalWerk Buermoos GMBH Arthrex Reciprocating Saw Attachment
Type: V-600SR
Distributed by: Arthrex Inc., Naples, Florida United States
The system Is a modular electric system, consisting of a handpiece drive, various acces Terminated |
HWE | None listed |
| Apr 4, 2011 | Linvatec Corp. dba ConMed Linvatec POUCH/CARTON LABEL:
***REF 5023-138***9.5 x 25.5 x 0.4mm***QTY 1***MICRO SAGITTAL BLADE, FINE***STERILE***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11211 CONCEPT BLVD LARGO, FL 33773-4908 USA***Mad Terminated |
HWE | None listed |
| Sep 13, 2010 | Stryker Instruments Div. of Stryker Corporation Stryker Bur Guard REF 2296-301, Stryker Instruments, Kalamazoo, MI (USA)
The Impaction Bur Guard is intended to be used with the Impaction Drill. The drill is used for surgical procedures involving pr Terminated |
HWE | K961970 |
| Oct 26, 2009 | Synthes USA (HQ), Inc. SYNTHES 2.0MM DRILL BIT STRYKER J-LATCH/60MM, Catalog # 317.853.
Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthognathic surgery. Terminated |
HWE | None listed |
| Oct 1, 2009 | Linvatec Corp. dba ConMed Linvatec MC5057 12ft/3.6 meters Universal Cable. Made in USA. NON STERILE Rx Only.
ConMed Linvatec, 11311 Concept Blvd, Largo, FL 33773.
The MC5057 Universal Cable, 12 ft, is used to connect electric handp Terminated |
HWE | None listed |
| Sep 8, 2009 | Biomet, Inc. Biomet 8.0MM cannulated reamer for the Aimer system, Biomet Sports Medicine, Ontario, CA; REF 909618. Terminated |
HWE | None listed |
| Mar 30, 2009 | Stryker Instruments Div. of Stryker Corporation Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300, & 5400-300; Stryker Instruments, Kalamazoo, MI.
Intended to be used with impaction Drill. Drill is used for surgical procedures invo Terminated |
HWE | K961970 |
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