FDA.reportPublic FDA data

JULIET ® INSTRUMENTATION

Primary DI
07640139343765
Brand
JULIET ® INSTRUMENTATION
Company
SpineArt SA
Model
LIN-00 00 07-N
Catalog number
LIN-00 00 07-N
Device description
SPREADER
Published
2019-02-01
Public version status
Update
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
07640139343765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640139343765076401393437657640139343765

GMDN Terms#

Term, Definition table
TermDefinition
Bone distraction forcepsA hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. 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
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
10886982357335VOLTSynthes GmbHHWN2026-09-25
10886982357342VOLTSynthes GmbHHWN2026-09-25
10886982357359VOLTSynthes GmbHHWN2026-09-25
10886982357366VOLTSynthes GmbHHWN2026-09-25
10886982357373VOLTSynthes GmbHHWN2026-09-25
10886982357380VOLTSynthes GmbHHWN2026-09-25
10886982357397VOLTSynthes GmbHHWN2026-09-25
10886982357403VOLTSynthes GmbHHWN2026-09-25
10886982357410VOLTSynthes GmbHHWN2026-09-25
10886982357427VOLTSynthes GmbHHWN2026-09-25
10886982357434VOLTSynthes GmbHHWN2026-09-25
10886982357441VOLTSynthes GmbHHWN2026-09-25
10886982357458VOLTSynthes GmbHHWN2026-09-25
10886982357465VOLTSynthes GmbHHWN2026-09-25
10886982357472VOLTSynthes GmbHHWN2026-09-25
10886982357489VOLTSynthes GmbHHWN2026-09-25
10886982357823VOLTSynthes GmbHHWN2026-09-25
10886982357830VOLTSynthes GmbHHWN2026-09-25
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
00810111225281Instrument TrayTreace Medical Concepts, Inc.HWN2026-03-30