FDA.reportPublic FDA data

ROMEO Posterior Osteosynthesis system

Primary DI
07640178971271
Brand
ROMEO Posterior Osteosynthesis system
Company
SpineArt SA
Model
ELL-R6 12 40-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
07640178971271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640178971271076401789712717640178971271

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length240Millimeter
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
07640221373021PERLA NAVNAV-IN 11 50-NNAV-IN 11 50-N2026-05-07
07640221373038PERLA ® TLHAN-FI BA 50-N2026-05-07
07640221373045PERLA ® TLTLF-IN 01 60-N2026-05-07
07640221373052PERLA NAVNAV-IN 43 30-NNAV-IN 43 30-N2026-05-07
07640221373069PERLA NAVNAV-IN 43 60-NNAV-IN 43 60-N2026-05-07
07640221373076PERLA ® TLTLF-IN 03 70-N2026-05-07
07640221373083PERLA ® TLTLF-IN 12 00-N2026-05-07
07640221373090PERLA ® TLTLF-IN 04 70-N2026-05-07
07640221373113PERLA NAVNAV-IN 41 75-NNAV-IN 41 75-N2026-05-07
07640221373120PERLA NAVNAV-IN 41 80-NNAV-IN 41 80-N2026-05-07
07640221373137PERLA NAVNAV-IN 41 85-NNAV-IN 41 85-N2026-05-07
07640221373144PERLA NAVNAV-IN 41 90-NNAV-IN 41 90-N2026-05-07
07640221373151PERLA NAVNAV-IN 41 95-NNAV-IN 41 95-N2026-05-07
07640221373168PERLA NAVNAV-IN 41 00-NNAV-IN 41 00-N2026-05-07
07640221373175PERLA NAVNAV-IN 41 05-NNAV-IN 41 05-N2026-05-07
07640221373182PERLA NAVNAV-IN 41 10-NNAV-IN 41 10-N2026-05-07
07640221373199PERLA NAVNAV-IN 41 15-NNAV-IN 41 15-N2026-05-07
07640221373205PERLA NAVNAV-IN 41 20-NNAV-IN 41 20-N2026-05-07
07640221373212PERLA NAVNAV-IN 41 25-NNAV-IN 41 25-N2026-05-07
07640221373229PERLA NAVNAV-IN 42 70-NNAV-IN 42 70-N2026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263066Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263066Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263073Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263073Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263080Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263080Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263097Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263097Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263103Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263103Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263110Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263110Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263127Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263127Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263134Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263134Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263141Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263141Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263158Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263158Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263165Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263165Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263172Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02
00840311263172Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263189Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-02
00840311263189Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-02