FDA.reportPublic FDA data

Reliance Buttress Washer System

Primary DI
00842566106938
Brand
Reliance Buttress Washer System
Company
VY SPINE LLC
Model
8-01-020
Catalog number
8-01-020
Device description
Buttress Washer-Narrow, 20mm
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
00842566106938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842566106938008425661069388425661069380842566106938

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal fusion cage, non-sterileA non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.

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

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