FDA.reportPublic FDA data

JULIET INSTRUMENTATION

Primary DI
07640178973565
Brand
JULIET INSTRUMENTATION
Company
SpineArt SA
Model
SPE-IN 00 52-N
Catalog number
SPE-IN 00 52-N
Device description
STRAIGHT OSTEOTOME
Published
2019-04-03
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
K133557000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133557000JULIET LL LATERAL LUMBAR CAGESpineart2014-02-03MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640178973565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640178973565076401789735657640178973565

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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
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
00843511102852Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102869Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102876Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102883Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102890Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102906Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102913Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00843511102920Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-18
00193982141097HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141103HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141110HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141127HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141134HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141141HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
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00193982141165HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141172HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141189HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
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00193982141264HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141271HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141288HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141295HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141301HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141318HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141325HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
00193982141332HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14