FDA.reportPublic FDA data

JULIET INSTRUMENTATION

Primary DI
07640178972704
Brand
JULIET INSTRUMENTATION
Company
SpineArt SA
Model
JUL-IN 03 09-N
Catalog number
JUL-IN 03 09-N
Device description
Bayoneted Penfield
Published
2018-02-08
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
K161888000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161888000JULIET® LL Lateral Lumbar CageSpineart2016-09-12MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640178972704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640178972704076401789727047640178972704

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery dissectorA hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. 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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00193982141110HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
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00193982141318HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14
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00193982141332HEDRONGLOBUS MEDICAL, INC.MAX2026-08-14