FDA.reportPublic FDA data

ROMEO 2 INSTRUMENTATION

Primary DI
07640178984165
Brand
ROMEO 2 INSTRUMENTATION
Company
SpineArt SA
Model
ELL-IN 00 52-N
Catalog number
ELL-IN 00 52-N
Device description
Derotation forceps
Published
2017-10-27
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
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640178984165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640178984165076401789841657640178984165

GMDN Terms#

Term, Definition table
TermDefinition
Implant handling forceps, alligatorA hand-held manual surgical instrument with blades designed to grasp and manipulate surgical implants/devices (excluding sutures) during implantation; it is not intended for use on soft tissues, not an ophthalmic device, and is not a dedicated tissue clip applier. It is shaped like alligator- or crocodile-forceps, having a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is made of high-grade stainless steel and is available in various sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
483016148
Device count
1
Premarket exempt
true
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
07640139342287Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 08-SDYN-BS 22 08-S2018-03-12
07640139342294Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 10-SDYN-BS 22 10-S2018-03-12
07640139342300Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 12-SDYN-BS 22 12-S2018-03-12
07640139342317Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 14-SDYN-BS 22 14-S2018-03-12
07640139343819Dynamik Intervertebral Body Fusion DeviceDYN-BS 22 16-SDYN-BS 22 16-S2018-03-12
07640151087500BGran® Synthetic Osteoconductive ScaffoldBGS-005BGS-0052017-09-18
07640151087517BGran® Synthetic Osteoconductive ScaffoldBGS-010BGS-0102017-09-18
07640151087524BGran® Synthetic Osteoconductive ScaffoldBGS-015BGS-0152017-09-18
07640151087531BGran® Synthetic Osteoconductive ScaffoldBGS-030BGS-0302017-09-18
07640151087654BGran® Synthetic Osteoconductive ScaffoldBGF-001BGF-0012017-09-18
07640151087661BGran® Synthetic Osteoconductive ScaffoldBGF-005BGF-0052017-09-18
07640151087678BGran® Synthetic Osteoconductive ScaffoldBGF-010BGF-0102017-09-18
07640151087685BGran® Synthetic Osteoconductive ScaffoldBGL-015BGL-0152017-09-18
07640151087692BGran® Synthetic Osteoconductive ScaffoldBGL-030BGL-0302017-09-18
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
M739153997700Cross Connector DriverCAPTIVA SPINE, INC.LXH2026-10-23
M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739243509000Implant Filling TubeCAPTIVA SPINE, INC.LXH2026-10-23
M739243511000Plunger RodCAPTIVA SPINE, INC.LXH2026-10-23
M739243512000Cannulated Drill, 7mmCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151066mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151077mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151088mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151099mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511010mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511111mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511212mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739983101200Coupling - Square ConnectCAPTIVA SPINE, INC.LXH2026-10-23
M739983240300Impaction T-HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739985202530Marking PinCAPTIVA SPINE, INC.LXH2026-10-23