| Device Type ID | 3699 |
| Device Name | Neurological Stereotaxic Instrument |
| Regulation Description | Stereotaxic Instrument. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.4560 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HAW |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3699 |
| Device | Neurological Stereotaxic Instrument |
| Product Code | HAW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Stereotaxic Instrument. |
| CFR Regulation Number | 882.4560 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACUMED LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARC SURGICAL LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BLUE ORTHO | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BRAINLAB AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CLARONAV INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DEERFIELD IMAGING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELEKTA INSTRUMENT AB | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FIAGON GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
FRED HAER COMPANY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLOBUS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTEGRA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTEGRA LIFESCIENCES CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IZI MEDICAL PRODUCTS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IZI MEDICAL PRODUCTS LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTECH S.A. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
MRI INTERVENTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ORTHOVITA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RENISHAW MAYFIELD SARL | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER LEIBINGER GMBH & CO. KG - NAVIGATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SYNAPTIVE MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Imprecision | 2126 |
Device Operates Differently Than Expected | 2018 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 1167 |
Communication Or Transmission Problem | 1104 |
Computer Software Problem | 939 |
Mechanical Problem | 752 |
Material Deformation | 729 |
Device Stops Intermittently | 726 |
Human-Device Interface Problem | 552 |
Break | 489 |
Device Displays Incorrect Message | 474 |
Monitor | 430 |
Disassembly | 402 |
No Display / Image | 398 |
Clamp | 352 |
Display Or Visual Feedback Problem | 352 |
Material Integrity Problem | 349 |
Adverse Event Without Identified Device Or Use Problem | 313 |
Unintended Movement | 301 |
Electrical /Electronic Property Problem | 275 |
Camera | 264 |
Screw | 250 |
Unintended Arm Motion | 214 |
CPU (Central Processing Unit Of Computer System) | 184 |
Output Problem | 174 |
Device Inoperable | 164 |
Use Of Device Problem | 155 |
Emitter | 149 |
Environmental Compatibility Problem | 149 |
Erratic Or Intermittent Display | 135 |
Fracture | 127 |
Cable | 124 |
Application Program Problem | 108 |
Bent | 88 |
Application Program Freezes, Becomes Nonfunctional | 83 |
Device Handling Problem | 83 |
Probe | 80 |
Improper Or Incorrect Procedure Or Method | 79 |
Calibration Problem | 75 |
Computer Hardware | 68 |
Driver | 63 |
Device Issue | 60 |
Mechanical Jam | 59 |
Guide | 58 |
Naturally Worn | 56 |
Unintended Collision | 50 |
Loose Or Intermittent Connection | 42 |
Power Cord | 36 |
Tip | 36 |
Unstable | 35 |
Battery | 34 |
Caster | 33 |
Failure To Obtain Sample | 32 |
Insufficient Information | 30 |
Material Twisted / Bent | 30 |
Positioning Problem | 28 |
Needle | 26 |
No Device Output | 26 |
Frame | 24 |
Component Missing | 24 |
Device Sensing Problem | 23 |
Image Display Error / Artifact | 23 |
Poor Quality Image | 23 |
Data Problem | 22 |
Device Operational Issue | 22 |
Failure To Calibrate | 22 |
Device Difficult To Setup Or Prepare | 21 |
Failure To Power Up | 20 |
Degraded | 19 |
Image Reversal | 18 |
Device Emits Odor | 18 |
Display | 17 |
Incorrect Software Programming Calculations | 17 |
LED (Light Emitting Diode) | 17 |
Defective Component | 16 |
Computer Operating System Problem | 16 |
Material Fragmentation | 15 |
Intermittent Communication Failure | 15 |
Screw Head | 14 |
Image Orientation Incorrect | 14 |
Locking Mechanism | 13 |
Unintended Application Program Shut Down | 13 |
Material Frayed | 12 |
Device Slipped | 12 |
Thread | 11 |
Appropriate Term/Code Not Available | 11 |
Improper Device Output | 10 |
Intermittent Loss Of Power | 9 |
Human Factors Issue | 8 |
Connector | 8 |
Connection Problem | 8 |
Misconnection | 7 |
Thermal Decomposition Of Device | 7 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 7 |
Device Damaged By Another Device | 7 |
Complete Blockage | 6 |
Detachment Of Device Component | 6 |
Device Contamination With Chemical Or Other Material | 6 |
Detachment Of Device Or Device Component | 6 |
Device Markings / Labelling Problem | 6 |
| Total Device Problems | 18328 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Brainlab AG | II | Jan-05-2018 |
| 2 | Brainlab AG | I | Jan-19-2016 |
| 3 | Brainlab AG | II | Nov-17-2015 |
| 4 | Brainlab AG | II | Nov-11-2015 |
| 5 | Brainlab AG | II | Aug-13-2014 |
| 6 | Brainlab AG | II | Apr-17-2014 |
| 7 | Brainlab AG | II | Feb-10-2014 |
| 8 | FHC, Inc. | II | Jul-05-2018 |
| 9 | Integra LifeSciences Corp. | II | Oct-06-2015 |
| 10 | MEDTECH SAS | II | Jun-07-2018 |
| 11 | Mazor Robotics Ltd | II | Dec-14-2018 |
| 12 | Medtronic Navigation, Inc. | I | Dec-29-2018 |
| 13 | Medtronic Navigation, Inc. | II | Jun-26-2017 |
| 14 | Medtronic Navigation, Inc. | II | Jan-11-2017 |
| 15 | Medtronic Navigation, Inc. | II | Aug-02-2016 |
| 16 | Medtronic Navigation, Inc. | II | Mar-24-2016 |
| 17 | Medtronic Navigation, Inc. | II | Sep-30-2015 |
| 18 | Medtronic Navigation, Inc. | II | Aug-03-2015 |
| 19 | Medtronic Navigation, Inc. | II | Jun-26-2015 |
| 20 | Medtronic Navigation, Inc. | II | Jun-12-2015 |
| 21 | Medtronic Navigation, Inc. | II | May-09-2014 |
| 22 | Medtronic Neuromodulation | II | Jul-25-2014 |
| 23 | Northern Digital Inc. | II | Jul-16-2015 |
| 24 | Northern Digital Inc. | II | Jul-16-2015 |
| 25 | Orthosoft, Inc. Dba Zimmer CAS | II | Jun-02-2017 |
| 26 | Orthosoft, Inc. Dba Zimmer CAS | III | May-12-2017 |
| 27 | Orthosoft, Inc. Dba Zimmer CAS | II | May-12-2017 |
| 28 | Orthosoft, Inc. Dba Zimmer CAS | II | May-08-2017 |
| 29 | Stryker Instruments Div. Of Stryker Corporation | II | Mar-27-2018 |
| 30 | Stryker Instruments Div. Of Stryker Corporation | II | Jun-16-2015 |
| 31 | Stryker Instruments Div. Of Stryker Corporation | II | Jun-04-2014 |
| 32 | Synaptive Medical Inc | I | Nov-26-2018 |
| 33 | Synaptive Medical, Inc. | II | Dec-23-2015 |
| 34 | Zimmer Biomet, Inc. | II | Feb-16-2018 |
| 35 | Zimmer Biomet, Inc. | II | Nov-28-2017 |
| 36 | Zimmer Biomet, Inc. | II | Nov-28-2017 |
| 37 | Zimmer Biomet, Inc. | II | Nov-21-2017 |
| 38 | Zimmer Biomet, Inc. | II | Nov-21-2017 |
| 39 | Zimmer Biomet, Inc. | II | Nov-20-2017 |
| 40 | Zimmer Biomet, Inc. | II | Nov-18-2017 |
| 41 | Zimmer Biomet, Inc. | II | Nov-18-2017 |
| 42 | Zimmer Biomet, Inc. | II | Nov-17-2017 |
| 43 | Zimmer Biomet, Inc. | II | Nov-16-2017 |
| 44 | Zimmer Biomet, Inc. | II | Nov-16-2017 |
| 45 | Zimmer Biomet, Inc. | II | Nov-16-2017 |
| 46 | Zimmer Biomet, Inc. | II | Nov-16-2017 |
| 47 | Zimmer Biomet, Inc. | II | Sep-12-2017 |
| 48 | Zimmer Biomet, Inc. | II | Aug-03-2017 |
| 49 | Zimmer Biomet, Inc. | II | Mar-27-2017 |