FDA.reportPublic FDA data

Annex® Adjacent Level System

Primary DI
10840642102727
Brand
Annex® Adjacent Level System
Company
Spine Wave, Inc.
Model
11-5047
Catalog number
11-5047
Device description
Implant No Jog Straight 5.5x45mm
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840642102727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084064210272710840642102727

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length45Millimeter
Outer Diameter5.5Millimeter

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10840642175370Annex® 2 Adjacent Level System13-826413-82642026-01-13
10840642175387Annex® 2 Adjacent Level System13-826513-82652026-01-13
10840642175394Annex® 2 Adjacent Level System13-826213-82622026-01-13
10840642176964Annex® 2 Adjacent Level System13-827313-82732026-01-13
10840642176971Annex® 2 Adjacent Level System13-827213-82722026-01-13
10840642178319Annex® 2 Adjacent Level System13-826613-82662026-01-13
10840642179330Annex® 2 Adjacent Level System13-826713-82672026-01-13
10840642135039Salvo® Spine System 11-673511-67352026-01-09
10840642135046Salvo® Spine System 11-673611-67362026-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935615Counter Torque STPREMIA SPINE LTDMNI2026-05-25
00763000887131CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887162CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887179CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00841732117860PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
00841732117877PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
00841732117884PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
00841732117891PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
00841732117907PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
00841732117914PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
00841732118959PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732118966PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732118973PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732118980PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119017PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119024PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119031PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119048PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119055PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119062PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119079PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
088000333846944CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847174CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847244CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847484CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847554CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847624CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847794CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847864CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333850974CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-12-11