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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 6, 2026United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Comp
Open, Classified
LXHNone listed
Aug 5, 2026United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 93
Open, Classified
LXHNone listed
Aug 5, 2026United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgica
Open, Classified
LXHNone listed
Aug 3, 2026Biomet, Inc.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
Open, Classified
LXHNone listed
Aug 3, 2026Biomet, Inc.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
Open, Classified
LXHNone listed
Aug 3, 2026Biomet, Inc.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
Open, Classified
LXHNone listed
Aug 3, 2026Biomet, Inc.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm
Open, Classified
LXHNone listed
Aug 3, 2026Biomet, Inc.
Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
Open, Classified
LXHNone listed
Apr 17, 2025Stryker GmbH
Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;
Open, Classified
LXHNone listed
Apr 17, 2025Stryker GmbH
Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;
Open, Classified
LXHNone listed
Mar 11, 2025DePuy Mitek, Inc., a Johnson & Johnson Co.
COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Open, Classified
LXHNone listed
Mar 11, 2025DePuy Mitek, Inc., a Johnson & Johnson Co.
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Open, Classified
LXHNone listed
Jan 22, 2025Integrity Implants Inc.
Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft materi
Open, Classified
LXHNone listed
Nov 27, 2024Gauthier Biomedical, Inc.
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Open, Classified
LXHNone listed
Oct 17, 2024Spineology, Inc.
The Graft Tube is an optional instrument which, as designed, can be filled with flowable graft material, then advanced through the Access Portal. A Push Rod is then used to facilitate the manual deplo
Open, Classified
LXHNone listed
Sep 24, 2024Waldemar Link GmbH & Co. KG (Corp. Hq.)
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Open, Classified
LXHNone listed
Aug 29, 2024ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL
FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System
Open, Classified
LXHK041393
Aug 20, 2024Intrinsic Therapeutics, Inc.
Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
Open, Classified
LXHNone listed
Jun 18, 2024Howmedica Osteonics Corp.
Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
Open, Classified
LXHNone listed
Jun 18, 2024Howmedica Osteonics Corp.
HRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900
Open, Classified
LXHNone listed
Feb 6, 2024Howmedica Osteonics Corp.
HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
Open, Classified
LXHNone listed
Feb 6, 2024Howmedica Osteonics Corp.
HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
Open, Classified
LXHNone listed
Dec 26, 2023Acumed LLC
RibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low Profile Primary Guide is an instrument used with a power system to compress the RibLoc plates onto the bone, d
Open, Classified
LXHNone listed
Dec 21, 2023Stryker Spine
LITe Decompression Snake Arm, REF 48080230
Open, Classified
LXHNone listed
Aug 29, 2023Waldemar Link GmbH & Co. KG (Mfg Site)
Link OptiStem Rasp Handle-Used with the OptiStem Rasp to prepare the femoral medullary canal for a knee prosthesis implant during a total knee arthroplasty surgical procedure Item Number: 17-5220/01
Open, Classified
LXHNone listed
Jul 3, 2023T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Betta Link LG Reusable Fishmouth Guide-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number
Open, Classified
LXHNone listed
Jul 3, 2023T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
Betta Link LG Reusable ProngED Guide - Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number
Open, Classified
LXHNone listed
Jul 3, 2023T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number
Open, Classified
LXHNone listed
Jul 3, 2023T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
BETTA LINK SR REUSABLE PRONGED GUIDE- Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries. Part Number:
Open, Classified
LXHNone listed
Jun 14, 2023Howmedica Osteonics Corp.
Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
Open, Classified
LXHNone listed
May 10, 2023Medtronic Sofamor Danek USA Inc
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
Open, Classified
LXHNone listed
Jun 29, 2022SONEX HEALTH LLC
SX-One MicroKnife
Terminated
LXHK192873
May 3, 2022Tornier, Inc
Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
Open, Classified
LXHK161742
Apr 29, 2022restor3d Inc.
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
Terminated
LXHNone listed
Apr 29, 2022restor3d Inc.
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Terminated
LXHNone listed
Apr 29, 2022restor3d Inc.
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
Terminated
LXHNone listed
Apr 13, 2022Medacta Usa Inc
GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
Terminated
LXHNone listed
Mar 25, 2022Arthrex, Inc.
K-Wire, 1.35 mm x 170 mm
Terminated
LXHNone listed
Dec 22, 2021Synthes (USA) Products LLC
Universal Chuck-The Universal Chuck is an Instrument Handle provided as an alternative instrument available for use in the TN-ADVANCED" Tibial Nailing System (TNA), TFN-ADVANCED" Proximal Femoral Nail
Open, Classified
LXHNone listed
Aug 18, 2021In2bones USA, LLC
CoLink Bone Graft Harvester, 8mm, Sterile, Disposable, REF G05 S1008 - Product Usage: is a general instrument intended for assisting surgeons in the manipulation of bone during surgical procedures.
Terminated
LXHNone listed
Jul 29, 2021Mizuho OSI
HANA/PROFx CLASSIC FEMORAL HOOK RIGHT REF 6850-144
Open, Classified
LXHNone listed
Jul 2, 2021Laboratoires Bodycad, Inc.
Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.
Terminated
LXHNone listed
Mar 26, 2021ConMed Corporation
KIT_INFINITY_BASE Custom Procedural Kit - Italy, containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament rec
Terminated
LXHNone listed
Mar 26, 2021ConMed Corporation
INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial Elbow and Tip Guides product line, KTE100 and KTT100. For use in open and arthroscopic procedures for knee ligament recons
Terminated
LXHNone listed
Nov 18, 2020Aesculap Implant Systems LLC
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Terminated
LXHNone listed
Nov 12, 2020ConMed Corporation
Infinity ACL Tibial Tip Guide- indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTT100
Terminated
LXHNone listed
Nov 12, 2020ConMed Corporation
Infinity ACL Tibial Elbow Guide-indicated for use in open and arthroscopic procedures for knee ligament reconstruction. Catalog Number: KTE100
Terminated
LXHNone listed
Nov 4, 2020K2M, Inc
Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Tool)-used to break the tab off the Everest XT screw by rocking the instrument back and forth until the entire tab is fully detached from th
Terminated
LXHNone listed
Jul 13, 2020Aesculap Implant Systems LLC
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Terminated
LXHNone listed
Jun 29, 2020Smith & Nephew, Inc.
PERI-LOC TARGETER 4.5MM DISTAL FEMUR, HANDLE, LEFT, NON-STERILE - Product Usage: used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC plates and screws are indicat
Terminated
LXHNone listed

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