FDA.reportPublic FDA data

WatchTower

Primary DI
04719876732378
Brand
WatchTower
Company
INTAI TECHNOLOGY CORP.
Model
INS-TAPC50
Device description
TAPC 5.0D
Published
2023-05-23
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
K230783000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230783000Anatase Spine Surgery Navigation SystemRemex Medical Corp.2023-04-21OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719876732378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719876732378047198767323784719876732378

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
10885862656117NewtonExactech, Inc.OLO2026-05-27
10885862656124NewtonExactech, Inc.OLO2026-05-27
10885862656131NewtonExactech, Inc.OLO2026-05-27
10885862656148NewtonExactech, Inc.OLO2026-05-27
10885862656155NewtonExactech, Inc.OLO2026-05-27
10885862656162NewtonExactech, Inc.OLO2026-05-27
10885862656179NewtonExactech, Inc.OLO2026-05-27
07613327594829Common Shoulder DriverMAKO SURGICAL CORP.OLO2026-05-21
07613327595543MakoMAKO SURGICAL CORP.OLO2026-05-21
07640221373021PERLA NAVSpineArt SAOLO2026-05-07
07640221373052PERLA NAVSpineArt SAOLO2026-05-07
07640221373069PERLA NAVSpineArt SAOLO2026-05-07
07640221373113PERLA NAVSpineArt SAOLO2026-05-07
07640221373120PERLA NAVSpineArt SAOLO2026-05-07
07640221373137PERLA NAVSpineArt SAOLO2026-05-07
07640221373144PERLA NAVSpineArt SAOLO2026-05-07
07640221373151PERLA NAVSpineArt SAOLO2026-05-07
07640221373168PERLA NAVSpineArt SAOLO2026-05-07
07640221373175PERLA NAVSpineArt SAOLO2026-05-07
07640221373182PERLA NAVSpineArt SAOLO2026-05-07
07640221373199PERLA NAVSpineArt SAOLO2026-05-07
07640221373205PERLA NAVSpineArt SAOLO2026-05-07
07640221373212PERLA NAVSpineArt SAOLO2026-05-07
07640221373229PERLA NAVSpineArt SAOLO2026-05-07
07640221373236PERLA NAVSpineArt SAOLO2026-05-07
07640221373243PERLA NAVSpineArt SAOLO2026-05-07
07640221373250PERLA NAVSpineArt SAOLO2026-05-07
07640221373267PERLA NAVSpineArt SAOLO2026-05-07
07640221373274PERLA NAVSpineArt SAOLO2026-05-07
07640221373281PERLA NAVSpineArt SAOLO2026-05-07