ClearanceBrief
Panels › Orthopedic › Product code LXH · Class 1

Orthopedic Manual Surgical Instrument

Regulation 888.4540

0510(k)s in 12 months (58 all time)
8recalls in 12 months (526 all time)
20recalls that name a 510(k)
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Top companies in LXH

DateFirm and productCodeLinked 510(k)
Sep 28, 2018TriMed Inc.
TriMed Peg Guide Extender, REF PEG-XTNDR, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Open, Classified
LXHNone listed
Sep 28, 2018TriMed Inc.
TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Open, Classified
LXHNone listed
Sep 28, 2018TriMed Inc.
TriMed Locking Drill Guide, 2.3mm, REF GUIDELCBS-2.3, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Open, Classified
LXHNone listed
Sep 28, 2018TriMed Inc.
TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.
Open, Classified
LXHNone listed
Sep 21, 2018DePuy Orthopaedics, Inc.
CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
Terminated
LXHNone listed
Sep 21, 2018DePuy Orthopaedics, Inc.
CORAIL AMT COXA VARA NECK SEGMENT (KLA) Pro. Code L20432 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
Terminated
LXHNone listed
Sep 21, 2018DePuy Orthopaedics, Inc.
CORAIL AMT STANDARD OFFSET NECK SEGMENT (STD), Pro. Code L20431 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.
Terminated
LXHNone listed
Sep 12, 2018Howmedica Osteonics Corp.
Tritanium TL Steerable Inserter, Cat. No. 48930000, UDI 07613327381900 Product Usage: The TL Steerable Inserter is a Class 1 instrument which is provided in a non-sterile condition. The inserter is d
Terminated
LXHNone listed
Aug 30, 2018DePuy Mitek, Inc., a Johnson & Johnson Co.
Mitek Screw and Washer Depth Gauge, Product Code 219024
Terminated
LXHNone listed
Jul 13, 2018Exactech, Inc.
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Terminated
LXHK152217
Jun 22, 2018Zimmer Biomet, Inc.
Persona Partial Knee System Spacer Block Alignment Tower, Item No. 42-5399-006-35 Product Usage: Intended to aid in preparatory surgical procedures
Terminated
LXHNone listed
Jun 18, 2018Zimmer Biomet, Inc.
Connecting Bolt, Model 14-442093
Terminated
LXHNone listed
Mar 26, 2018Zimmer Biomet, Inc.
ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
Terminated
LXHNone listed
Mar 26, 2018Zimmer Biomet, Inc.
ZMS Intramedullary Fixation Smooth Guide Wire 2.4 mm Diameter, 100 cm Length; Item Number: 47-2237-033-00
Terminated
LXHNone listed
Mar 26, 2018Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00
Terminated
LXHNone listed
Mar 26, 2018Zimmer Biomet, Inc.
Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
Terminated
LXHNone listed
Mar 26, 2018Zimmer Biomet, Inc.
Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
Terminated
LXHNone listed
Mar 26, 2018Zimmer Biomet, Inc.
ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
Terminated
LXHNone listed
Mar 26, 2018Zimmer Biomet, Inc.
Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00
Terminated
LXHNone listed
Mar 26, 2018Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00
Terminated
LXHNone listed
Mar 5, 2018Synthes, Inc.
Flex Arm Product Usage: The Synthes Flex Arm is a component of the Synthes Minimally Invasive Support System, which provides secure table mounting for minimally invasive spine surgery. The Flex Arm i
Terminated
LXHNone listed
Jan 11, 2018TriMed Inc.
Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO;
Terminated
LXHNone listed
Dec 22, 2017DePuy Mitek, Inc., a Johnson & Johnson Co.
LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedic surgeon with a means of bone fixation and to assist
Terminated
LXHNone listed
Dec 20, 2017Ad-Tech Medical Instrument Corporation
Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile. The drill bits are 30cm long and made of stainless steel. The drill kits are supplied in a st
Terminated
LXHNone listed
Nov 9, 2017Stryker Instruments Div. of Stryker Corporation
Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
Terminated
LXHNone listed
Oct 24, 2017Zimmer Biomet, Inc.
Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery
Terminated
LXHNone listed
Oct 3, 2017Zimmer Biomet, Inc.
Sirus Drill 13mm diameter trauma instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 02.00020.040
Terminated
LXHNone listed
Oct 3, 2017Zimmer Biomet, Inc.
Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04
Terminated
LXHNone listed
Sep 13, 2017Zimmer Biomet, Inc.
979195 Loaner Kit for femoral intramedullary nail. Orthopedic instrument.
Terminated
LXHNone listed
Sep 13, 2017Zimmer Biomet, Inc.
14-442000S Antegrade Femoral Nail Instrument Kit, orthopedic instrument
Terminated
LXHNone listed
Sep 13, 2017Zimmer Biomet, Inc.
Phoenix Antegrade Femoral Nail Trochanteric and Piriformis fossa, Model#14-442093 Antegrade Femoral Connecting Bolt. orthopedic instrument
Terminated
LXHNone listed
Sep 8, 2017Howmedica Osteonics Corp.
AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement bet
Terminated
LXHNone listed
Sep 8, 2017Limacorporate S.p.A
Delta Cup Beater Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System
Completed
LXHK141395
Jul 26, 2017DePuy Orthopaedics, Inc.
Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
Terminated
LXHNone listed
Jun 26, 2017Implant Direct Sybron Manufacturing, LLC
Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant p
Terminated
LXHNone listed
Jun 19, 2017Exactech, Inc.
Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifica
Terminated
LXHNone listed
Jun 19, 2017Exactech, Inc.
Logic Fit Tibial Tamp Head
Terminated
LXHNone listed
Jun 12, 2017Zimmer Biomet, Inc.
DRILL BIT MINI QUICK CONNECT 1.0MM, REF 2312-20-200 & 2312-20-202, NON STERILE
Terminated
LXHNone listed
Jun 5, 2017Zimmer Biomet, Inc.
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of
Terminated
LXHNone listed
Jun 5, 2017Zimmer Biomet, Inc.
Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length, Item Number 47-2490-098-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of
Terminated
LXHNone listed
Jun 5, 2017Zimmer Biomet, Inc.
Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length, Item Number 47-2255-008-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary ca
Terminated
LXHNone listed
Jun 5, 2017Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Humeral Guide Wire - Bullet Tip 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-026-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used du
Terminated
LXHNone listed
Jun 5, 2017Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only, Item Number 00-2255-025-00 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during
Terminated
LXHNone listed
Apr 25, 2017Zimmer Biomet, Inc.
Bone Dowell Harvest Tubes
Terminated
LXHNone listed
Apr 25, 2017Amendia, Inc
01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used
Terminated
LXHNone listed
Apr 13, 2017Medtronic Sofamor Danek USA Inc
Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Terminated
LXHNone listed
Mar 16, 2017Acumed LLC
.045 X 6 ST Guide Wire, Part number 45-0029-S, Sterile 10 pack of WS-1106ST and has a 6 inch length and 0.045 inch diameter. .054 X 7 ST Guide Wire, Part number 45-0031-S, Sterile 10 Pack of WS-1407
Terminated
LXHNone listed
Mar 1, 2017United Orthopedic Corporation
UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
Terminated
LXHNone listed
Feb 27, 2017Synthes (USA) Products LLC
PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy
Terminated
LXHNone listed
Jan 13, 2017Vertebral Technologies, Inc.
InterFuse Tail Traction Tool, Part Number 9116. The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse
Terminated
LXHNone listed

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