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)
Top companies in OLO
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 23, 2016 | Mako Surgical Corporation RESTORIS PST RIO Offset Shell Impactor
For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery. Terminated |
OLO | K121064 |
| Nov 25, 2015 | Mako Surgical Corporation MAKOplasty Hip Array Kit Laminate 150230 Terminated |
OLO | K121064 |
| Nov 5, 2015 | Mako Surgical Corporation Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacem Terminated |
OLO | K112507 K121064 |
| Oct 29, 2015 | Zimmer Biomet, Inc. Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device
The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons Terminated |
OLO | K151511 |
| Sep 30, 2015 | Medtronic Navigation, Inc. P/N: 9735023, DRIVER 9735023 SOLERA 5.5/6.0 MAS; P/N: 9735024, DRIVER 9735024 SOLERA 5.5/6.0 MAS CAN;
P/N: 9735025, DRIVER 9735025 SOLERA 5.5/6.0 RMAS; P/N: 9735026, DRIVER 9735026 SOLERA 5.5/6.0 RMA Terminated |
OLO | K124004 |
| Jun 2, 2015 | Zimmer CAS Tibial Alignment Guide; Orthopedic Stereotaxic Instrument; Terminated |
OLO | K122326 |
| Feb 26, 2015 | Brainlab AG The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instr Terminated |
OLO | K122011 |
| Feb 19, 2015 | Mako Surgical Corporation Restoris Partial Knee Application (PKA) RIO (TGS 2.0).
For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures. Terminated |
OLO | K112507 |
| Dec 18, 2014 | Mako Surgical Corporation RESTORIS PST Acetabular Offset Shell Impactors
An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup co Terminated |
OLO | K121064 |
| Dec 18, 2014 | Mako Surgical Corporation RESTORIS PST Acetabular Straight Shell Impactors
An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup Terminated |
OLO | K121064 |
| Dec 18, 2014 | Mako Surgical Corporation RESTORIS PST Straight Shell Inserter
An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components d Terminated |
OLO | K121064 |
| May 9, 2014 | Blue Belt Technologies MN NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020. Terminated |
OLO | K121936 |
| Nov 19, 2012 | Mako Surgical Corporation The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000).
The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anat Terminated |
OLO | K081867 |
| Nov 1, 2011 | Mako Surgical Corporation Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL ARM, 201251 RIO GUIDANCE MODULE, 200294 RIO CAMERA STAND ASSEMBLY***PN 203999 SN ROB 125 2010-12 V 100/120/230 A 9 Terminated |
OLO | K093425 |
| Nov 18, 2010 | Smith & Nephew Inc smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1
Product is intended to be an intraoperative image-guided localization system. It is a computer Terminated |
OLO | K100107 |
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