FDA.reportPublic FDA data

PathFinder NXT Minimally Invasive Pedicle Screw System

Primary DI
03662663193863
Brand
PathFinder NXT Minimally Invasive Pedicle Screw System
Company
Highridge Medical, LLC
Model
3555-020
Catalog number
3555-020
Device description
Pat Handle Pathfinder® NXT
Published
2025-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, spondylolisthesis spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03662663193863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663193863036626631938633662663193863

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

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
Lot or batch
true
Manufacturing date on label
true
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
M719GL2290TiLockGenesys Orthopedics Systems LLCMNH2026-07-14
04047844129418DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129425DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129432DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129449DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129456DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129463DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129470DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129487DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129494DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129500DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129517DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129524DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129531DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129548DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129555DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129562DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129579DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129586DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129593DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129609DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129616DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129623DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129630DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129647DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129654DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129661DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129678DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129685DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
04047844129692DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13