FDA.reportPublic FDA data

Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation System

Primary DI
03662663153898
Brand
Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation System
Company
Highridge Medical, LLC
Model
14-525111
Catalog number
14-525111
Device description
SMALL NUT
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKGPosterior cervical screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662663153898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663153898036626631538983662663153898

GMDN Terms#

Term, Definition table
TermDefinition
Implantable bone nutA small, implantable block threaded on its inside surface designed to be threaded outside a bone bolt or screw (not included) for secure fastening/stabilisation. It is not intended to be internally threaded to the bolt/screw (i.e., it is not a set screw). It is made of metallic or non-metallic materials. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)447-3625usbrocustomerservice@highridgemedical.com

Regulatory Flags#

DUNS number
119260394
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03662663273350Timberline Lateral Fusion System8734-00308734-00302025-12-18
00887868381034Virage 3.0mm tapered Tap 14mm lengthLV01586LV015862026-04-30
00887868523083The TetherLV01666LV016662026-04-22
008884805002164.75mm Reamer ProbeLV00568LV005682026-04-15
00887868259814Radiolucent Pedicle ProbeLV01446LV014462026-04-07
03662663194457SC-AcuFix Anterior Cervical Plate System457-1457-12026-03-31
03662663194464SC-AcuFix Anterior Cervical Plate System474-1474-12026-03-31
03662663194471SC-AcuFix Anterior Cervical Plate System479-1479-12026-03-31
03662663199155Silhouette Spinal Fixation System7010-0003-007010-0003-002026-03-31
03662663199162Silhouette Spinal Fixation System7010-0011-007010-0011-002026-03-31
03662663199179Silhouette Spinal Fixation System7010-0013-007010-0013-002026-03-31
03662663199186Silhouette Spinal Fixation System7010-0014-007010-0014-002026-03-31
03662663199193Silhouette Spinal Fixation System7010-0015-007010-0015-002026-03-31
03662663199209Silhouette Spinal Fixation System7010-0084-007010-0084-002026-03-31
03662663199216Silhouette Spinal Fixation System7010-0133-007010-0133-002026-03-31
03662663199223Silhouette Spinal Fixation System7010-0152-017010-0152-012026-03-31
03662663130929Zyston Interbody Spacer System136M3306136M33062026-03-17
03662663130936Zyston Interbody Spacer System136M3307136M33072026-03-17
03662663131117Zyston Interbody Spacer System139M2606139M26062026-03-17
03662663136693Polaris 5.5 Spinal Fixation System14-50181014-5018102026-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982521134QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521141QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521158QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521165QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521172QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521189QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521196QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521202QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521219QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521226QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521233QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521240QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521257QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521264QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00193982521271QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00889095368611QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00889095368628QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00889095368635QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00889095368642QUARTEXGLOBUS MEDICAL, INC.NKG2026-08-14
00840606193382Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193399Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193405Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193412Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193429Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193436Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193443Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606193450Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194044Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194051Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30
00840606194068Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-30