FDA.reportPublic FDA data

ROMEO 2 INSTRUMENTATION

Primary DI
07640139342188
Brand
ROMEO 2 INSTRUMENTATION
Company
SpineArt SA
Model
ELL-IN 01 16-N
Catalog number
ELL-IN 01 16-N
Device description
Screwdriver Shaft SS
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111127000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111127000ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEMSpineart2011-08-11MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640139342188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640139342188076401393421887640139342188

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
483016148
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640332476345PERLA ®NAV-IN BR 00-NNAV-IN BR 00-N2025-11-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197157082185ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082192ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082208ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082215ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082222ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082239ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082246ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082253ZAVATION SCREWZavation LLCKWP2026-07-23
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00197157082277ZAVATION SCREWZavation LLCKWP2026-07-23
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00197157082291ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082307ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082314ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082321ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082338ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082345ZAVATION SCREWZavation LLCKWP2026-07-23
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00197157082369ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082376ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082383ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082390ZAVATION SCREWZavation LLCKWP2026-07-23
00197157082406ZAVATION SCREWZavation LLCKWP2026-07-23
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00197157082420ZAVATION SCREWZavation LLCKWP2026-07-23