FDA.reportPublic FDA data

ROMEO Posterior Osteosynthesis system

Primary DI
07640178987814
Brand
ROMEO Posterior Osteosynthesis system
Company
SpineArt SA
Model
ELL-R6 12 00-S
Catalog number
ELL-R6 12 00-S
Device description
Rod Cobalt Chromium / Prebent
Published
2018-04-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141835000ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM PREBENT CROSS-CONNECTORS; PREBENT RODSSpineart2014-09-10MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640178987814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640178987814076401789878147640178987814

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
Length200Millimeter
Outer Diameter5.4Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
483016148
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640139343185BAGUERA C INSTRUMENTATIONCDP-IN 30 01-N2026-08-27
07640221370884TRYPTIK® TiTRY-BX 40 01-N2026-08-27
07640178972452ROMEO posterior osteosynthesis systemNAV-IN 01 00-NNAV-IN 01 00-N2019-01-31
07640221370891BAGUERA® CBAG-CT 13 05-S2026-08-21
07640221370907BAGUERA® CBAG-CT 13 06-S2026-08-21
07640221370914BAGUERA® CBAG-CT 13 07-S2026-08-21
07640221370921BAGUERA® CBAG-CT 14 05-S2026-08-21
07640221370938BAGUERA® CBAG-CT 14 06-S2026-08-21
07640221370945BAGUERA® CBAG-CT 14 07-S2026-08-21
07640221370952BAGUERA® CBAG-CT 16 05-S2026-08-21
07640221370969BAGUERA® CBAG-CT 16 06-S2026-08-21
07640221370976BAGUERA® CBAG-CT 16 07-S2026-08-21
07640139343079BAGUERA® CCDP-IN 00 03-N2026-08-19
07640221370525BAGUERA® CCDP-IN 00 07-N2026-08-19
07640221370532BAGUERA® CCDP-IN 00 06-N2026-08-19
07640221370549BAGUERA® CCDP-IN 61 00-N2026-08-19
07640221370556BAGUERA® CCDP-IN 60 01-N2026-08-19
07640221370563BAGUERA® CCDP-IN SM 05-N2026-08-19
07640221370570BAGUERA® CCDP-IN ME 05-N2026-08-19
07640221370587BAGUERA® CCDP-IN LA 05-N2026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857037953EVEREST® Spinal SystemVB Spine LLCMNH2026-06-11
10888857037953EVEREST® Spinal SystemVB Spine LLCMNI2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCMNI2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCMNH2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCMNH2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857008724EVEREST® Spinal SystemVB Spine LLCMNI2016-03-10
10888857008724EVEREST® Spinal SystemVB Spine LLCMNH2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001497DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCMNH2015-09-24