FDA.report

Vital MIS Spinal Fixation System

Primary DI
03662663161961
Brand
Vital MIS Spinal Fixation System
Company
Highridge Medical, LLC
Model
850M0001
Catalog number
850M0001
Device description
Vital™ MIS Jamshidi T - Trocar
Published
2026-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GDFGUIDE, NEEDLE, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663161961PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. 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
true
Serial number
false
Manufacturing date on label
true
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
03662663161220PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCGDF2026-02-16
03662663161237PathFinder NXT Minimally Invasive Pedicle Screw SystemHighridge Medical, LLCGDF2026-02-16
00850031983014OCCIGUIDEVAULT PARAGON GROUP, INC.GDF2026-01-07
03662663244442Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDF2025-12-18
03662663244466Vital MIS Spinal Fixation SystemHighridge Medical, LLCGDF2025-12-18
03662663276412Timberline Lateral Fusion SystemHighridge Medical, LLCGDF2025-12-18
03662663276429Timberline Lateral Fusion SystemHighridge Medical, LLCGDF2025-12-18
03662663276788Timberline Lateral Fusion SystemHighridge Medical, LLCGDF2025-11-17
03662663135924Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCGDF2025-11-14
20197344044792MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
20197344044808MEDLINEMEDLINE INDUSTRIES, INC.GDF2025-09-23
00194613059095MSI Precision Specialty InstrumentsMed Saver, Inc.GDF2025-08-01
10850012846434PicoDriverLSI Solutions, Inc.GDF2025-07-19
05010058179820InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058182639InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058182646InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058183643InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-23
05010058182622InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-06-18
05010058178953InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-05-21
05010058179943InstrapacROBINSON HEALTHCARE LIMITEDGDF2025-05-21
04049047675808GimmiGimmi GmbHGDF2025-05-06
04049047675815GimmiGimmi GmbHGDF2025-05-06
04049047675884GimmiGimmi GmbHGDF2025-05-06
04049047675891GimmiGimmi GmbHGDF2025-05-06
04049047675907GimmiGimmi GmbHGDF2025-05-06
04049047675945GimmiGimmi GmbHGDF2025-05-06
04049047675952GimmiGimmi GmbHGDF2025-05-06
04049047675969GimmiGimmi GmbHGDF2025-05-06
04049047675976GimmiGimmi GmbHGDF2025-05-06
04049047676287GimmiGimmi GmbHGDF2025-05-06