FDA.reportPublic FDA data

IMPLANET SPINE SYSTEM

Primary DI
03607503502382
Brand
IMPLANET SPINE SYSTEM
Company
IMPLANET
Model
Offset Rod to Rod Connector
Catalog number
350238
Device description
Offset Rod to Rod Connector
Published
2015-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
OSHPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143731000IMPLANET Spine System (ISS)Implanet, S.A.2015-04-14NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03607503502382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03607503502382036075035023823607503502382

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter4Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
291993439
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03607505700755Jazz Spinal System5700755700752026-04-02
03607506310632Jazz Spinal System6310636310632026-04-02
03607506310656Jazz Spinal System6310656310652026-04-02
03607506310663Jazz Spinal System6310666310662026-04-02
03607506310779Jazz Spinal System6310776310772026-04-02
03607506313473Jazz Spinal System6313476313472026-04-02
03607506313527Jazz Spinal System6313526313522026-04-02
03607506317020Jazz Spinal System6317026317022026-04-02
03607506335932Jazz Spinal System6335932026-04-02
03607506340417Jazz Spinal System6340412026-04-02
03607506343623Jazz Spinal System6343622026-04-02
03607506343784Jazz Spinal System6343782026-04-02
03607506344569Jazz Spinal System6344562026-04-02
03607506344576Jazz Spinal System6344572026-04-02
03607506344583Jazz Spinal System6344582026-04-02
03607506344613Jazz Spinal System6344612026-04-02
03607506344620Jazz Spinal System6344622026-04-02
03607505700830Jazz Spinal System5700835700832025-11-28
03607506348512Jazz Spinal System6348512025-11-18
03607506348529Jazz Spinal System6348522025-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-06-28
00643169101296MSB VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-27
10889981441555VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441555VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981005115NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005115NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005115NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationNKB2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationMNI2015-09-24