FDA.reportPublic FDA data

JULIET INSTRUMENTATION

Primary DI
07640139342430
Brand
JULIET INSTRUMENTATION
Company
SpineArt SA
Model
DYN-IP 00 05-N
Catalog number
DYN-IP 00 05-N
Device description
Nerve Root Retractor
Published
2018-03-12
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
K153621000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153621000Juliet® TiSpineart2016-07-15MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640139342430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640139342430076401393424307640139342430

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
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
07640221370860SCALASLA-BX 20 02-N2026-07-24
07640221373663SCALASLA-IN 01 01-N2026-07-24
07640221373670SCALASLA-IN 01 02-N2026-07-24
07640221373687SCALASLA-IN 02 00-N2026-07-24
07640221373694SCALASLA-IN 03 01-N2026-07-24
07640221373700SCALASLA-IN 03 02-N2026-07-24
07640221373717SCALASLA-IN 04 01-N2026-07-24
07640221373724SCALASLA-IN 04 02-N2026-07-24
07640221373731SCALASLA-IN 04 03-N2026-07-24
07640221373748SCALASLA-IN 05 01-N2026-07-24
07640221373755SCALASLA-IN 05 02-N2026-07-24
07640221373762SCALASLA-IN 05 03-N2026-07-24
07640221373779SCALASLA-IN 06 01-N2026-07-24
07640221373786SCALASLA-IN 06 02-N2026-07-24
07640221373793SCALASLA-IN 06 03-N2026-07-24
07640332476345PERLA ®NAV-IN BR 00-NNAV-IN BR 00-N2025-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843511102586Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102593Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102609Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102616Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102623Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102630Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102647Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102654Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102661Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102678Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102685Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102692Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102708Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102715Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102722Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102739Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102746Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102753Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102760Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102777Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102784Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102791Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102807Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102814Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102821Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102838Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00843511102845Omnia Medical TiBrid™-TSOMNIA MEDICAL, LLCMAX2026-08-03
00810166521604X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521611X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30
00810166521765X-PACEXPANDING INNOVATIONS, INC.MAX2026-07-30