FDA.reportPublic FDA data

JULIET ® INSTRUMENTATION

Primary DI
07640178982819
Brand
JULIET ® INSTRUMENTATION
Company
SpineArt SA
Model
JLL-IN 11 01-N
Catalog number
JLL-IN 11 01-N
Device description
STRAIGHT IMPACTOR
Published
2019-01-14
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWNInstrument, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640178982819PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640178982819076401789828197640178982819

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft packing blockA device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. 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
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
07640221370594BAGUERA® CCDP-IN SM 06-N2026-08-19
07640221370600BAGUERA® CCDP-IN ME 06-N2026-08-19
07640221370617BAGUERA® CCDP-IN LA 06-N2026-08-19
07640221370624BAGUERA® CCDP-IN 00 08-N2026-08-19
07640221370631BAGUERA® CCDP-BX 20 01-N2026-08-19
07640221370648BAGUERA® CCDP-BX 20 02-N2026-08-19
07640221370655BAGUERA® CLID-BX 16 00-N2026-08-19
07640221370877BAGUERA® CCDP-BX 10 03-N2026-08-19
07640332471623PERLA TL NAVNAV-IN 51 31-NNAV-IN 51 31-N2025-11-20
07640332476338PERLA ®AST-IN EC 00-NAST-IN EC 00-N2025-11-20
07640221370846SCALASLA-BX 20 00-N2026-07-24
07640221370853SCALASLA-BX 20 01-N2026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083430009SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00850083430047SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00850083430078SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00850083430092SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00810111228374Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-07-17
00810111228381Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-07-17
00840311251148Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251155Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251162Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251179Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251377Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311262953Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-27
00810111225281Instrument TrayTreace Medical Concepts, Inc.HWN2026-03-30
00840311245451Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-03-18
00810111226691Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-02-20
00818345029774RIVA Posterior Fixation SystemXENIX MEDICAL LLCHWN2026-01-12
00810111226677Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
00810111226684Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
00810111226707Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
15060238201596Femoral Cement PressuriserSUMMIT MEDICAL LIMITEDHWN2025-01-10
00840298704637Songer® Spinal Cable SystemPioneer Surgical Technology, Inc.HWN2024-08-23
00841732164246GENERIC Surgical InstrumentsCTL Medical CorporationHWN2023-09-15
00841732164185GENERIC Surgical InstrumentsCTL Medical CorporationHWN2023-09-14
00643169350991Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWN2022-10-08
G079C5060000010Golden Isles Pedicle Screw SystemIntelivation, LLCHWN2022-09-23
00613994878137n/aMEDTRONIC SOFAMOR DANEK, INC.HWN2022-08-06
00721902875755N/AMEDTRONIC SOFAMOR DANEK, INC.HWN2022-08-06
20886982313437NASynthes GmbHHWN2022-07-29
20886982313444NASynthes GmbHHWN2022-07-29
20886982313451NASynthes GmbHHWN2022-07-29