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Panels › Neurology › Product code OLO · Class 2

Orthopedic Stereotaxic Instrument

Regulation 882.4560

47510(k)s in 12 months (444 all time)
13recalls in 12 months (115 all time)
113recalls that name a 510(k)
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Top companies in OLO

DateFirm and productCodeLinked 510(k)
Aug 8, 2022Mako Surgical Corporation
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
Terminated
OLOK121064
Mar 11, 2022DePuy Orthopaedics, Inc.
VELYS Robotic-Assisted Solution Base Product No.: 451570100
Terminated
OLOK202769
Jan 7, 2022Orthosoft, Inc. dba Zimmer CAS
NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
Open, Classified
OLOK110054
Nov 19, 2020Mako Surgical Corporation
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the dist
Completed
OLOK142350
Nov 2, 2020RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Streamline OCT Navigated Instruments, Catalog numbers 26-DRILL-MDN 26-FTAP-30-MDN 26-FTAP-35-MDN 26-FTAP-40-MDN 26-FTAP-40-MDN 26-FTAP-45-MDN 26-S-FINDER-MDN Components of a surgical navigation de
Open, Classified
OLOK200095
Oct 27, 2020RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TAP-85-L-MDN 02-C-TAP-85-MDN 02-C-TAP-95-L-MDN 02-RS-INS-C-MD
Terminated
OLOK200095
Oct 27, 2020RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-
Terminated
OLOK200095
Sep 11, 2020RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Streamline MIS Navigation System Taps, Catalog numbers 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN
Terminated
OLOK200095
Sep 10, 2020Blue Ortho
Instructions For Use document of the GPS Trackers.
Terminated
OLOK193618
Aug 20, 2020Brainlab AG
Cirq Arm System - Model SBS 1.3.2 (Art.No. 56000-01B) and SBS 1.4 (Art.No. 56000-01C) of the CIRQ Arm System (56000 and 56000A)
Terminated
OLOK183605
Jul 31, 2020Mako Surgical Corporation
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Terminated
OLOK141989
Jul 16, 2020Brainlab AG
BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
Terminated
OLOK183605
Jul 16, 2020Brainlab AG
BRAINLAB Curve; Model/catalogue (article) numbers for Curve: 19901; 19901B; 19900; 19905 UDI (GTIN) for Curve: 04056481138011
Terminated
OLOK183605
Jun 9, 2020Medtronic Navigation, Inc.
Mazor X Surgical System Positioner Type II, REF: ASM0214-02
Open, Classified
OLOK182077
Apr 10, 2020Medtronic Navigation, Inc.
NavLock Tracker *** Rx Only
Terminated
OLOK171267
K182104
Feb 27, 2020Smith & Nephew, Inc.
NAVIO Soft Tissue Protector, included in instrument kits. The NAVIO Tissue Protector is a reusable instrument designed to, when used as instructed, provide the required bone pin spacing for the Navi
Terminated
OLOK121936
Feb 11, 2020Intellijoint Surgical, Inc.
Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-oper
Terminated
OLOK191507
Sep 22, 2019Blue Ortho
Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002
Terminated
OLOK152764
Aug 8, 2019Intellijoint Surgical, Inc.
Workstation, G2, Configured (P/N 000-0241)
Terminated
OLOK172849
Jul 2, 2019Mazor Robotics Ltd
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
Terminated
OLOK182077
Apr 25, 2019Mako Surgical Corporation
2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
Terminated
OLOK143752
Apr 25, 2019Mako Surgical Corporation
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
Terminated
OLOK143752
Apr 12, 2019OMNIlife science Inc.
OMNIBotics iBlock Cutting Guide, 4146-1000 - Product Usage: The OMNIBotics iBlock Cutting Guide is a stainless-steel surgical instrument used during total knee arthroplasty. Specifically, the iBlock C
Terminated
OLOK090953
Dec 6, 2018Medtronic Navigation, Inc.
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 00763000054915), contained in the following kits: Upgrade Set Percutaneous Pin, REF 9735502 (GTIN 0064
Terminated
OLOK131425
Aug 24, 2018Mako Surgical Corporation
Stryker Mako Vizadisc Hip Procedure Tracking Kit
Terminated
OLOK121064
Aug 24, 2018Mako Surgical Corporation
Stryker Mako Vizadisc Knee Procedure Tracking Kit
Terminated
OLOK112507
May 10, 2018Mako Surgical Corporation
Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the sur
Terminated
OLOK170891
Mar 30, 2018Think Surgical, Inc.
Think Surgical Cutter, Flat, 6.2mm x 144mm. For use only with the TCAT Computer-Assisted Tool. Part Number 106428 The cutter is used to prepare the bone for the (TKA) Total Knee Arthroplasty.
Terminated
OLONone listed
Jan 18, 2018Exactech, Inc.
Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Terminated
OLOK162567
Dec 27, 2017Mako Surgical Corporation
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical kn
Terminated
OLOK170581
K170584 +2
Dec 1, 2017Mako Surgical Corporation
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Terminated
OLOK170584
K170891
Aug 7, 2017Mako Surgical Corporation
Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation an
Terminated
OLOK121064
K141989
Aug 7, 2017Mako Surgical Corporation
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for o
Terminated
OLOK112507
Jun 29, 2017Medtronic Navigation, Inc.
Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intende
Terminated
OLOK131425
Jun 29, 2017Medtronic Navigation, Inc.
Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigi
Terminated
OLOK131425
Jun 29, 2017Medtronic Navigation, Inc.
Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid
Terminated
OLOK131425
Jun 29, 2017Medtronic Navigation, Inc.
Spine Referencing Instrumentation, Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attac
Terminated
OLOK131425
Jun 29, 2017Medtronic Navigation, Inc.
Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attach
Terminated
OLOK131425
Jun 7, 2017Mako Surgical Corporation
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
Terminated
OLOK112507
May 1, 2017Zimmer Biomet, Inc.
ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.
Terminated
OLOK151511
Apr 26, 2017Orthosoft, Inc. dba Zimmer CAS
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
Terminated
OLOK110054
Mar 27, 2017Zimmer Biomet, Inc.
MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments
Terminated
OLOK151511
Feb 20, 2017Orthosoft, Inc. dba Zimmer CAS
SmartTools Knee System Orthopedic Stereotaxic Instrument
Terminated
OLOK122326
Dec 22, 2016Mako Surgical Corporation
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Terminated
OLOK121064
K141989
Dec 2, 2016K2M, Inc
K2M Special Connector Instruments (Special Connector, Special Adaptor, and Quick Adaptor) Product Usage: Special Connector Instruments include an additional feature on their shafts that enable surgeo
Terminated
OLOK171321
Nov 17, 2016OMNI LIFE SCIENCE
OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation System with iBlock (Now OMNIBotics) is intended for use during stereotaxic surgery to aid the surgeon in locating anatomic
Terminated
OLOK090953
Oct 27, 2016Brainlab AG
Femoral and Tibial Cutting Block Adapter Base. Brainlab knee, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic
Terminated
OLOK102990
Sep 29, 2016Mako Surgical Corporation
Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
Terminated
OLOK121064
Jul 18, 2016Medtronic Navigation, Inc.
Synergy Spine. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product Usage: The StealthStation System is intended as an aid for pr
Terminated
OLOK131425
Apr 18, 2016Mako Surgical Corporation
Robotic Arm Interactive Orthopedic System (RIO)
Terminated
OLOK112507
K121064

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