FDA.reportPublic FDA data

UNI-THREAD®

Primary DI
03663136019802
Brand
UNI-THREAD®
Company
SPINEVISION
Model
L2-RC610LT
Device description
Ti 6.5mm x 100mm Left Rod Connector
Published
2015-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052406000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052406000UNI-THREAD SPINAL SYSTEMSpine Vision, Inc.2005-11-07MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663136019802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663136019802036631360198023663136019802

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
390377518
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03663136001869C3® ACPSC1-P1 02652015-10-15
03663136001876C3® ACPSC1-P1 0265N12015-10-15
03663136001883C3® ACPSC1-P1 02902015-10-15
03663136001913C3® ACPSC1-P1 0315N12015-10-15
03663136001944C3® ACPSC1-P1 03652015-10-15
03663136002095C3® ACPSC1-P2 0540N12015-10-15
03663136002170C3® ACPSC1-P3 06902015-10-15
03663136002262C3® ACPSC1-P4 08902015-10-15
03663136002309C3® ACPSC1-P4 10502015-10-15
03663136019482C3® ACPSC1-L1 03902015-10-15
03663136019574C3® ACPSC1-L3 05702015-10-15
03663136001821C3® ACPSC1-P1 02152015-10-15
03663136001838C3® ACPSC1-P1 0215N12015-10-15
03663136001845C3® ACPSC1-P1 02402015-10-15
03663136001852C3® ACPSC1-P1 0240N12015-10-15
03663136001890C3® ACPSC1-P1 0290N12015-10-15
03663136001920C3® ACPSC1-P1 03402015-10-15
03663136001937C3® ACPSC1-P1 0340N12015-10-15
03663136001951C3® ACPSC1-P1 0365N12015-10-15
03663136001968C3® ACPSC1-P1 03902015-10-15

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Primary DI, Brand, Company table
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04047844129432DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
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04047844129449DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129456DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129456DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129463DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129463DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129470DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129470DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129487DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129487DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129494DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129494DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129500DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129500DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129517DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129517DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129524DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129524DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129531DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129531DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129548DIPLOMAT FTSIGNUS Medizintechnik GmbHMNI2026-07-13
04047844129548DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13