FDA.reportPublic FDA data

Virage® OCT

Primary DI
03662663079853
Brand
Virage® OCT
Company
Highridge Medical, LLC
Model
300P0012
Catalog number
300P0012
Device description
Head-to-Rod Channel Connector (Ø3.5mm/4.0mm - Ø3.5mm/4.0mm)
Published
2025-01-10
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
03662663079853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663079853036626630798533662663079853

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

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
04052536085491neon3Ulrich GmbH & Co. KGNKG2026-05-28
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07630345705877M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705884M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705891M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705907M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705914M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705921M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705938M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705945M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705952M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630971299559M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299566M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
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07630971299528M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-25
07630971299535M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-25
07630971299542M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-25
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07630971299375M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299382M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299399M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299405M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299412M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299429M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299436M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299443M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299450M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299467M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19