FDA.reportPublic FDA data

JULIET ® Ti INSTRUMENTATION

Primary DI
07640185349100
Brand
JULIET ® Ti INSTRUMENTATION
Company
SpineArt SA
Model
JIR-IN 00 02-N
Catalog number
JIR-IN 00 02-N
Device description
INSERT/ROTATE IMPLANT HOLDER
Published
2021-03-24
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181203000Juliet TiSpineart2018-06-28MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640185349100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640185349100076401853491007640185349100

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant/trial-implant/sizer holder, reusableA hand-held manual surgical instrument designed to connect to and hold an orthopaedic implant (e.g., bone screw, bone graft), trial implant, or sizer (e.g., glenoid defect sizer) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during an orthopaedic surgical intervention. The instrument is typically made of high-grade stainless steel or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end (e.g., a threaded portion or a clamp mechanism). 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
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
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.MAX2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMAX2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217669CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19