FDA.report

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

Primary DI
03662663153829
Brand
Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation System
Company
Highridge Medical, LLC
Model
14-525066
Catalog number
14-525066
Device description
DEPTH GAUGE W/ HOOK
Published
2025-11-17
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
HTJGAUGE, DEPTH

Product Code Classifications

CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663153829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03662663153829036626631538293662663153829

GMDN Terms

TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

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
08809945895076EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-03-23
00810111225649Depth GageTreace Medical Concepts, Inc.HTJ2026-03-19
10885862661449N/AExactech, Inc.HTJ2026-03-19
00840124525450Depth GaugeFUSION ORTHOPEDICS, LLCHTJ2026-03-06
08809945895021EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895038EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895045EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895052EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895069EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895083EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895090EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895106EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895113EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
00810112597486TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTJ2026-02-10
06438394001534Activa InstrumentBioretec OyHTJ2026-01-30
06438394001541Activa InstrumentBioretec OyHTJ2026-01-30
06438394005266Activa InstrumentBioretec OyHTJ2026-01-28
00840124525191DynaBridgeFUSION ORTHOPEDICS, LLCHTJ2026-01-19
00840124525207DynaBridgeFUSION ORTHOPEDICS, LLCHTJ2026-01-19
00840124525214DynaBridgeFUSION ORTHOPEDICS, LLCHTJ2026-01-19
00841731135520Redemption VILEX LLCHTJ2026-01-13
00841506137520ProteanSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
00841506138077ProteanSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
00841506138947Proximal Humerus Plating SystemSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
00841506145945Proximal Humerus Plating SystemSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
04262494462580N/ADoppkon GmbH & Co. KGHTJ2025-12-01
08056693027987INTRAUMA SURGICAL INSTRUMENTINTRAUMA SPAHTJ2025-11-27
08800068959690LOSPA Surgical InstrumentsCorentec Co., LtdHTJ2025-11-25
08800068959706LOSPA Surgical InstrumentsCorentec Co., LtdHTJ2025-11-25
08800068959713LOSPA Surgical InstrumentsCorentec Co., LtdHTJ2025-11-25