FDA.reportPublic FDA data

Anatase Spine Surgery Navigation System

Primary DI
04719876737250
Brand
Anatase Spine Surgery Navigation System
Company
INTAI TECHNOLOGY CORP.
Model
NAVTL0007
Device description
TAP 5.0D
Published
2023-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220348000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220348000Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-VRemex Medical Corporation2022-07-14OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719876737250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719876737250047198767372504719876737250

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(561) 277-9480info@captivaspine.com

Regulatory Flags#

DUNS number
658683227
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719874670443ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0CS3901L2026-05-04
04719874670207ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS050152026-04-22
04719874670221ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS135102026-04-22
04719874670238ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS135112026-04-22
04719874670245ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS135132026-04-22
04719874670252ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS135152026-04-22
04719874670269ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS140082026-04-22
04719874670276ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS140102026-04-22
04719874670283ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS140112026-04-22
04719874670290ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS140132026-04-22
04719874670306ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS140152026-04-22
04719874670313ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS145082026-04-22
04719874670320ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS145102026-04-22
04719874670214ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS135082026-04-20
04719874670337ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS142112026-04-20
04719874670344ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS145132026-04-20
04719874670351ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS145152026-04-20
04719874670368ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS150082026-04-20
04719874670375ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS150102026-04-20
04719874670382ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEMDI0FS150112026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190376658933Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376658940Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376659053Valence Robotic Navigation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376729374Invictus Spinal Fixation SystemALPHATEC SPINE, INC.OLO2026-10-29
00190376729435Invictus Spinal Fixation SystemALPHATEC SPINE, INC.OLO2026-10-29
04056481147648Quip Link Instrument Tracking Array For 3 Marker Spheres MBrainlab SEOLO2026-10-29
04056481147655Quip Link Instrument Tracking Array For 3 Marker Spheres MLBrainlab SEOLO2026-10-29
04056481147662Quip Link Instrument Tracking Array For 3 Marker Spheres LBrainlab SEOLO2026-10-29
04056481147679Quip Link Instrument Tracking Array For 3 Marker Spheres L1Brainlab SEOLO2026-10-29
04056481147686Quip Link Instrument Tracking Array For 3 Marker Spheres L2Brainlab SEOLO2026-10-29
04056481147693Quip Instrument Adapter Clamp Size SBrainlab SEOLO2026-10-29
04056481147709Quip Instrument Adapter Clamp Softgrip Size MBrainlab SEOLO2026-10-29
04056481147716Quip Instrument Adapter Clamp Softgrip Size LBrainlab SEOLO2026-10-29
04056481147723Quip Instrument Adapter Clamp Softgrip Size XLBrainlab SEOLO2026-10-29
04056481147730Quip Instrument Adapter Clamp For Rectangular InstrumentsBrainlab SEOLO2026-10-29
04056481147747Quip Instrument Adapter Clamp For Cylindrical InstrumentsBrainlab SEOLO2026-10-29
04056481147754Quip Instrument Adapter Extension 50 mmBrainlab SEOLO2026-10-29
04056481147761Quip Instrument Adapter 45° AngledBrainlab SEOLO2026-10-29
04250337121626joimax® Intracs® EM Patient Tracker 3DJoimax GmbHOLO2026-10-29
04250337118985J-Needle Navi WL 120, trocar, 11 GJoimax GmbHOLO2026-10-28
00887868578922ROSA® KneeOrthosoft IncOLO2026-10-27
00887868578939ROSA Partial Knee SoftwareOrthosoft IncOLO2026-10-27
00887868581090ROSA® RoboticsOrthosoft IncOLO2026-10-27
00887868581106ROSA® RoboticsOrthosoft IncOLO2026-10-27
00889024671270ROSA® HipOrthosoft IncOLO2026-10-27
04056481145323Patient Reference Carbon-Clamp Spine & TraumaBrainlab SEOLO2026-10-27
04056481148201Sterilization Tray Accessories SpineBrainlab SEOLO2026-10-27
04056481148218Sterilization Tray Accessories Spine & TraumaBrainlab SEOLO2026-10-27
04056481148225Sterilization Tray Accessories Spine MISBrainlab SEOLO2026-10-27
00852776006713CORUS Navigation Access System-G2LXProvidence Medical Technology, Inc.OLO2026-10-26