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
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423456RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08