FDA.report

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

Primary DI
03662663153478
Brand
Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation System
Company
Highridge Medical, LLC
Model
14-525027
Catalog number
14-525027
Device description
LINEUM COMPRESSOR
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HWNINSTRUMENT, COMPRESSION

Product Code Classifications

CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663153478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03662663153478036626631534783662663153478

GMDN Terms

TermDefinition
Osteotomy compression/distraction instrumentA non-sterile manual surgical instrument intended to be used for compression and distraction of an osteotomy. It is comprised of two arms that attach to pins/screws/nails inserted into both sides of the cut bone, and includes a mechanism (e.g., screw) used to close and open the arms of the device enabling compression and distraction at the osteotomy line. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)447-3625usbrocustomerservice@highridgemedical.com

Regulatory Flags

DUNS number
119260394
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
03662663136709Polaris 5.5 Spinal Fixation System14-50181114-5018112026-03-17
03662663136723Polaris 5.5 Spinal Fixation System14-50181314-5018132026-03-17
03662663143462MaxAn Anterior Cervical Plate System14-52203814-5220382026-03-17
03662663143479MaxAn Anterior Cervical Plate System14-52203914-5220392026-03-17
03662663143486MaxAn Anterior Cervical Plate System14-52204014-5220402026-03-17
03662663143493MaxAn Anterior Cervical Plate System14-52204114-5220412026-03-17
03662663143509MaxAn Anterior Cervical Plate System14-52204214-5220422026-03-17
03662663143516MaxAn Anterior Cervical Plate System14-52204314-5220432026-03-17
03662663143523MaxAn Anterior Cervical Plate System14-52204414-5220442026-03-17
03662663143530MaxAn Anterior Cervical Plate System14-52204514-5220452026-03-17
03662663085458FlareHawkASY-00003ASY-000032025-10-03
03662663085502FlareHawkASY-00018ASY-000182025-10-03
03662663085533FlareHawkASY-00040ASY-000402025-10-03
03662663085540FlareHawkASY-00041ASY-000412025-10-03
03662663085632FlareHawkASY-00064ASY-000642025-10-03
03662663085663FlareHawkASY-00067ASY-000672025-10-03

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B922F005003608ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHWN2026-03-11
G079C5080000140MIS Golden Isles Pedicle Screw System Intelivation, LLCHWN2026-01-30
00199150061983Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWN2026-01-15
00888480530817Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHWN2026-01-13
03662663217040Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHWN2026-01-13
00840180543733General InstrumentsALPHATEC SPINE, INC.HWN2025-12-31
00840180544037General InstrumentsALPHATEC SPINE, INC.HWN2025-12-31
03662663244718Vital MIS Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-18
03662663198196Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-17
00840124525061Metalogix RevolutionFUSION ORTHOPEDICS, LLCHWN2025-12-16
03662663162326Zyston Interbody Spacer SystemHighridge Medical, LLCHWN2025-12-16
03662663195850Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195867Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195928Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195935Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195942Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195959Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195966Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195973Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663195980Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663196000Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663196017Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
03662663198189Alpine XC Adjustable Fusion SystemHighridge Medical, LLCHWN2025-12-15
00888480484912Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
00888480484929Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
00888480484936Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
03662663113199Virage OCT Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
03662663125895Vital MIS Spinal Fixation SystemHighridge Medical, LLCHWN2025-12-03
03662663136884Polaris 4.75 Deformity SystemHighridge Medical, LLCHWN2025-12-03
03662663136891Polaris 4.75 Deformity SystemHighridge Medical, LLCHWN2025-12-03