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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)
Aug 22, 2011Smith & Nephew, Inc. Endoscopy Division
Smith & Nephew, Tendon Stripper, Slotted, 5.0 mm I.D. x 12 working length. Non-Sterile Catalog Number: 013554 Orthopedic Manual Surgical Instrument
Terminated
LXHNone listed
Aug 1, 2011Biomet Microfixation, Inc.
"***BIOMET MICROFIXATION***CENTER DRIVE STAINLESS STEEL***2.0MM SYSTEM SCREWDRIVER BLADE***Non-Sterile Product***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofix
Terminated
LXHNone listed
Jun 30, 2011Biomet, Inc.
Comprehensive Shoulder Instruments Fracture Stem Inserter w/Version Control, REF 31-406901, Biomet Orthopedics Warsaw, IN, Instrument used to introduce the stem into the canal. The instrument is used
Terminated
LXHNone listed
Jun 30, 2011Biomet, Inc.
Comprehensive Shoulder Instruments Primary Shoulder Stem Inserter, REF 407398, Biomet Orthopedics Warsaw, IN, Instrument used to introduce the stem into the canal. The instrument is used to insert th
Terminated
LXHNone listed
Mar 22, 2011Depuy Orthopaedics, Inc.
AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc., Warsaw, IN; DePuy International Leeds, England.
Terminated
LXHK100238
Mar 16, 2011Stryker Howmedica Osteonics Corp.
SCORPIO-FLEX CR TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. The Tibial trial are utilized during surgery to assess the overall compone
Terminated
LXHNone listed
Mar 16, 2011Stryker Howmedica Osteonics Corp.
SCORPIO-FLEX PS TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. The Tibial trial are utilized during surgery to assess the overall compon
Terminated
LXHNone listed
Mar 16, 2011Stryker Howmedica Osteonics Corp.
SCORPIO PS TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. The Tibial trial are utilized during surgery to assess the overall component f
Terminated
LXHNone listed
Feb 22, 2011Depuy Orthopaedics, Inc.
S-ROM Distal Femoral Cutting block Guide SZ MED, REF 216311004, non-sterile, Depuy International Leeds, England. The product is used to make cuts in the femur to prepare the femur for total knee rep
Terminated
LXHNone listed
Feb 22, 2011Depuy Orthopaedics, Inc.
S-ROM Distal Femoral Cutting block Guide SZ X- SM/SM, REF 216311001, non-sterile, Depuy International Leeds, England. The product is used to make cuts in the femur to prepare the femur for total knee
Terminated
LXHNone listed
Feb 15, 2011Stryker Spine
Mantis Tap Sleeve,Mfg by: Stryker Spine, 2 Pearl Court, Allendale, NJ 07401-1677. packaged in the following products: Specialty Mantis Modular Tap Set - Catalog #IS2162MAN; Custom Tap Sleeve - Catalo
Terminated
LXHNone listed
Jan 19, 2011Stryker Howmedica Osteonics Corp.
Scorpio Fixed Femoral A/P Sizing Guide; non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corporation The A/P sizer is designed to set
Terminated
LXHNone listed
Jan 19, 2011Stryker Howmedica Osteonics Corp.
Scorpio Adjustable Femoral A/P Sizing Guide Assembly; non-sterile instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; A subsidiary of Stryker Corporation The A/P sizer is d
Terminated
LXHNone listed
Jan 12, 2011Stryker Spine
Disc Space Distractor Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 Used to assist in spinal fusions. It is to be placed between the vert
Terminated
LXHNone listed
Jan 10, 2011Zimmer Inc.
TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01, Zimmer, Warsaw, IN. The Zimmer Title 2 counter torque assembly tool is a reuseable, non- implantable surgical tool that
Terminated
LXHNone listed
Dec 28, 2010Biomet, Inc.
Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. This instrument is used to prepare the tibial cancellous bone for the tibial offset tray.
Terminated
LXHNone listed
Dec 27, 2010Stryker Howmedica Osteonics Corp.
CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, & Specialty Head Center Accolade Broach Handle; Stryker Howmedica Osteonics, Non-sterile Instruments; Howmedica Osteonics Corp., 325 Corporate
Terminated
LXHNone listed
Dec 13, 2010Zimmer Inc.
NexGen Complete Knee Solution Rotating Hinge Knee tibial broach impactor, Catalog # 00-5881-080-00, Zimmer Inc., Warsaw, IN.
Terminated
LXHNone listed
Dec 13, 2010Zimmer Inc.
NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN.
Terminated
LXHK042271
K072619 +3
Nov 26, 2010Stryker Howmedica Osteonics Corp.
T2 Ankle Arthrodesis System Nail and Nut Adapter; Stryker Trauma GmbH, Germany; Distributed in USA by Howmedica, Osteonics Corp., 325 Corporate Drive, Mahwah, NJ
Terminated
LXHNone listed
Oct 15, 2010Zimmer Inc.
Continuum Acetabular Systems Shell Inserter Adapter without Rotational Control, 00-8790-003-10, Zimmer Inc., Warsaw, IN. Used to mate the inserter with the shell implant.
Terminated
LXHK091508
Oct 15, 2010Zimmer Inc.
Continuum Acetabular Systems Shell Inserter Adapter with Rotational Control, 00-8790-003-00, Zimmer Inc., Warsaw, IN. Used to mate the inserter with the shell implant.
Terminated
LXHK091508
Oct 13, 2010Stryker Howmedica Osteonics Corp.
Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone
Terminated
LXHNone listed
Oct 13, 2010Stryker Howmedica Osteonics Corp.
Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone
Terminated
LXHNone listed
Oct 13, 2010Stryker Howmedica Osteonics Corp.
Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone
Terminated
LXHNone listed
Oct 13, 2010Stryker Howmedica Osteonics Corp.
Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone
Terminated
LXHNone listed
Oct 13, 2010Stryker Howmedica Osteonics Corp.
Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone
Terminated
LXHNone listed
Oct 13, 2010Stryker Howmedica Osteonics Corp.
Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone
Terminated
LXHNone listed
Oct 13, 2010Stryker Howmedica Osteonics Corp.
Scorpio/ NRG 4 in1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone c
Terminated
LXHNone listed
Oct 13, 2010Stryker Howmedica Osteonics Corp.
Scorpio/ NRG 4in1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cu
Terminated
LXHNone listed
Oct 13, 2010Stryker Howmedica Osteonics Corp.
Scorpio/ NRG 4in1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cu
Terminated
LXHNone listed
Oct 6, 2010Depuy Orthopaedics, Inc.
Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the
Terminated
LXHNone listed
Sep 30, 2010Encore Medical, Lp
Glenoid Head Inserter (RSP Inserter/Impactor), Device Part #804-03-041, All Lots. Product is a Shoulder Instrument used to place the Glenoid Head Trial onto the Baseplate
Terminated
LXHNone listed
Sep 28, 2010Biomet, Inc.
8 MM DISPOSABLE CORING TREPHINE STAGGERED TEETH WITH PROTECTION SLEEVE, REF 900788, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.
Terminated
LXHNone listed
Sep 28, 2010Biomet, Inc.
10 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900740, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.
Terminated
LXHNone listed
Sep 28, 2010Biomet, Inc.
9 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900739, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.
Terminated
LXHNone listed
Sep 28, 2010Biomet, Inc.
8 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900738, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.
Terminated
LXHNone listed
Sep 28, 2010Biomet, Inc.
7 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.
Terminated
LXHNone listed
Sep 28, 2010Biomet, Inc.
10 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900730, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.
Terminated
LXHNone listed
Sep 28, 2010Biomet, Inc.
9 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900729, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.
Terminated
LXHNone listed
Sep 28, 2010Biomet, Inc.
8 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900728, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.
Terminated
LXHNone listed
Sep 28, 2010Biomet, Inc.
7 MM DISPOSABLE CORING TREPHINE WITH PROTECTION SLEEVE, REF 900727, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.
Terminated
LXHNone listed
Sep 25, 2010Biomet, Inc.
Modular Microplasty Cup impactor 1/4" - 28 thread insert , REF 31-400605
Terminated
LXHNone listed
Sep 25, 2010Biomet, Inc.
Modular Microplasty Cup inserter 3/8" thread , REF 31-400600
Terminated
LXHNone listed
Aug 26, 2010Zimmer Inc.
Zimmer ITST" INTERTROCHANTERIC/SUBTROCHANTERIC FIXATION LOCKING BOLT EXTRACTOR - NONSTERILE Zimmer, Warsaw, IN 46580, U.S.A. The ITST Intertrochanteric/Subtrochanteric Fixation Locking Bolt Extractor
Terminated
LXHNone listed
Aug 24, 2010Linvatec Corp. dba ConMed Linvatec
C-REAMER CANNULATED, STERILE, Rx ONLY. REF 8772A, 9.0MM, QTY DIST 712. REF 8773A, 10MM, QTY DIST 1,244. REF 8774A, 11MM, QTY DIST 384 REF 8775A, 12MM, QTY DIST 156 CONMED LINVATEC, 11311 CONC
Terminated
LXHNone listed
Aug 24, 2010Linvatec Corp. dba ConMed Linvatec
REF 8788, 8mm C-REAMER, CANNULATED, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in Arthroscopic knee procedures.
Terminated
LXHNone listed
Aug 24, 2010Linvatec Corp. dba ConMed Linvatec
REF 8787, 7mm C-REAMER, CANNULATED, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in Arthroscopic knee procedures.
Terminated
LXHNone listed
Aug 24, 2010Linvatec Corp. dba ConMed Linvatec
REF 8586, 6mm C-REAMER, CANNULATED, STERILE, Rx ONLY. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in Arthroscopic knee procedures.
Terminated
LXHNone listed
Aug 2, 2010Encore Medical, Lp
MIKA Speedblock, Size 8-12. The MIKA Speedblock is placed on the distal femur as a guide for making the anterior, posterior and both chamfer cuts.
Terminated
LXHNone listed

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