FDA.reportPublic FDA data

Advanced Research Medical Trident SI Screw System

Primary DI
00840239800329
Brand
Advanced Research Medical Trident SI Screw System
Company
ADVANCED RESEARCH MEDICAL LLC
Model
03-13
Catalog number
03-13
Device description
Insulating Sleeve
Published
2021-04-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OURSacroiliac Joint Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203373000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203373000Advanced Research Medical Trident SI Screw SystemAdvanced Research Medical, LLC2021-01-22OUR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239800329PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239800329008402398003298402398003290840239800329

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6124401865info@advresmed.com

Regulatory Flags#

DUNS number
117201206
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
00850014575038Lumbar Interbody Fusion System (OLLIF)01-200101-20012019-12-16
00850014575076Lumbar Interbody Fusion System (OLLIF)01-271001-27102019-12-16
00850014575083Lumbar Interbody Fusion System (OLLIF)01-271101-27112019-12-16
00850014575090Lumbar Interbody Fusion System (OLLIF)01-271201-27122019-12-16
00850014575106Lumbar Interbody Fusion System (OLLIF)01-271301-27132019-12-16
00850014575113Lumbar Interbody Fusion System (OLLIF)01-271401-27142019-12-16
00850014575120Lumbar Interbody Fusion System (OLLIF)01-271501-27152019-12-16
00850014575144Lumbar Interbody Fusion System (OLLIF)01-300801-30082019-12-16
00850014575151Lumbar Interbody Fusion System (OLLIF)01-300901-30092019-12-16
00850014575168Lumbar Interbody Fusion System (OLLIF)01-301001-30102019-12-16
00850014575175Lumbar Interbody Fusion System (OLLIF)01-301101-30112019-12-16
00850014575182Lumbar Interbody Fusion System (OLLIF)01-301201-30122019-12-16
00850014575199Lumbar Interbody Fusion System (OLLIF)01-301301-30132019-12-16
00850014575205Lumbar Interbody Fusion System (OLLIF)01-301401-30142019-12-16
00850014575212Lumbar Interbody Fusion System (OLLIF)01-301501-30152019-12-16
00850014575229Lumbar Interbody Fusion System (OLLIF)01-331501-33152019-12-16
00850014575236Lumbar Interbody Fusion System (OLLIF)01-331401-33142019-12-16
00850014575243Lumbar Interbody Fusion System (OLLIF)01-331301-33132019-12-16
00850014575250Lumbar Interbody Fusion System (OLLIF)01-331201-33122019-12-16
00850014575267Lumbar Interbody Fusion System (OLLIF)01-331101-33112019-12-16

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