FDA.reportPublic FDA data

Trinica/Trinica Select Anterior Cervical Plate System

Primary DI
03662663107464
Brand
Trinica/Trinica Select Anterior Cervical Plate System
Company
Highridge Medical, LLC
Model
07.00117.010
Catalog number
07.00117.010
Device description
Self Tapping Variable Screw
Published
2025-11-14
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
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662663107464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663107464036626631074643662663107464

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
10888857596894OZARK Cervical Plate SystemVB Spine LLCKWQ2026-05-28
00840354204958Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204965Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204972Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204989Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204996Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205009Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205016Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205023Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205030Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205047Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
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00840354205122Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205139Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205146Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205153Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205160Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205177Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205184Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205191Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205207Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354203654Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203661Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203678Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06