FDA.reportPublic FDA data

UNI-THREAD®

Primary DI
03663136019765
Brand
UNI-THREAD®
Company
SPINEVISION
Model
L2-L200T
Device description
M6 plug
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
K013301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013301000UNI-T SPINAL SYSTEMSpine Vision, Inc.2002-02-13MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663136019765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663136019765036631360197653663136019765

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone set screwA small, threaded, implantable, non-bioabsorbable disc intended to be threaded into the proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-06-28
10889981065348MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065348MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065577MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065577MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065584MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065584MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065607MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065607MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065645MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065645MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981065669MarinerSeaspine Orthopedics CorporationMNI2016-09-02
10889981065669MarinerSeaspine Orthopedics CorporationMNH2016-09-02
10889981005115NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005115NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005139NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005146NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005290NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationMNI2015-09-24
10889981005306NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005313NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005313NewportSeaspine Orthopedics CorporationMNI2015-09-24