FDA.reportPublic FDA data

Reliance Buttress Washer System

Primary DI
00842566106969
Brand
Reliance Buttress Washer System
Company
VY SPINE LLC
Model
8-45-030
Catalog number
8-45-030
Device description
Buttress Washer Screw 4.5x30mm
Published
2016-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K073349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073349000RELIANCE BUTTRESS WASHER SYSTEMReliance Medical Systems, LLC2008-02-13KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842566106969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842566106969008425661069698425661069690842566106969

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, sterile, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold plates, or other stabilization device, to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
801-295-3280info@reliance-medical.net

Regulatory Flags#

DUNS number
049592888
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840283403460LumiVy™03-T-0927-0-06-PET-R2026-06-05
00840283403897VySpan™05-CRR7-3535-TI-N2026-06-05
00840283403927VySpan™05-CRR10-3540-TI-N2026-06-05
00840283407949VyPlate™06-IPH-0022026-06-05
00840283403477LumiVy™03-T-0927-0-07-PET-R2026-04-30
00840283403484LumiVy™03-T-0927-0-08-PET-R2026-04-30
00840283403491LumiVy™03-T-0927-0-09-PET-R2026-04-30
00840283403507LumiVy™03-T-0927-0-10-PET-R2026-04-30
00840283403514LumiVy™03-T-0927-0-11-PET-R2026-04-29
00840283403521LumiVy™03-T-0927-0-12-PET-R2026-04-28
00840283403538LumiVy™03-T-0927-0-13-PET-R2026-04-28
00840283403545LumiVy™03-T-0927-0-14-PET-R2026-04-28
00840283403552LumiVy™03-T-0927-0-15-PET-R2026-04-28
00840283403576LumiVy™03-A-3427-6-09-PET-R2026-04-27
00840283403583LumiVy™03-A-3427-6-10-PET-R2026-04-27
00840283403590LumiVy™03-A-3427-6-11-PET-R2026-04-27
00840283403606LumiVy™03-A-3427-6-12-PET-R2026-04-27
00840283403613LumiVy™03-A-3427-6-13-PET-R2026-04-27
00840283403620LumiVy™03-A-3427-6-14-PET-R2026-04-27
00840283403569LumiVy™03-A-3427-6-08-PET-R2026-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000859404CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-18
00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-18
20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-07-18
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13