FDA.reportPublic FDA data

PathFinder NXT Minimally Invasive Pedicle Screw System

Primary DI
03662663194198
Brand
PathFinder NXT Minimally Invasive Pedicle Screw System
Company
Highridge Medical, LLC
Model
3572-1
Catalog number
3572-1
Device description
Modular T-Handle, 1/4 in (6.35 mm) Square, 3-Position Ratcheting Torque Limiting 90 in-lbs (10.2 N•m)
Published
2025-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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
03662663194198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03662663194198036626631941983662663194198

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, 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, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)447-3625usbrocustomerservice@highridgemedical.com

Regulatory Flags#

DUNS number
119260394
Device count
1

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04047844129463DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13
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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
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04047844129692DIPLOMAT FTSIGNUS Medizintechnik GmbHMNH2026-07-13