FDA.reportPublic FDA data

Annex® Adjacent Level System

Primary DI
10840642107821
Brand
Annex® Adjacent Level System
Company
Spine Wave, Inc.
Model
10-5012
Catalog number
10-5012
Device description
Annex® Rod Trial, No Jog, Medium
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840642107821PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084064210782110840642107821

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
203-944-9494GUDID@spinewave.com

Regulatory Flags#

DUNS number
067789763
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840642107739Bifurcated Retractor Illuminator SWC-04SWC-042016-09-25
10840642174410Salvo® Spine System21-003921-00392026-04-13
10840642174434Salvo® Spine System21-004121-00412026-04-13
10840642174632Salvo® Spine System21-006121-00612026-04-13
10840642174649Salvo® Spine System21-006221-00622026-04-13
10840642174694Salvo® Spine System21-006721-00672026-04-13
10840642174878Salvo® Spine System21-008521-00852026-04-13
10840642174892Salvo® Spine System21-008721-00872026-04-13
10840642174915Salvo® Spine System21-008921-00892026-04-13
10840642160703Salvo® Spine System11-864911-86492026-03-17
10840642134322Salvo® Spine System11-666411-66642026-01-30
10840642134339Salvo® Spine System11-666511-66652026-01-30
10840642134346Salvo® Spine System11-666611-66662026-01-30
10840642177008Proficient® Posterior Cervical Spine System11-874411-87442026-01-15
10840642177794Proficient® Posterior Cervical Spine System11-874911-87492026-01-15
10840642175325Annex® 2 Adjacent Level System13-826813-82682026-01-13
10840642175332Annex® 2 Adjacent Level System13-826913-82692026-01-13
10840642175349Annex® 2 Adjacent Level System13-827013-82702026-01-13
10840642175356Annex® 2 Adjacent Level System13-827113-82712026-01-13
10840642175363Annex® 2 Adjacent Level System13-826313-82632026-01-13

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