FDA.report

Vail OCT Spinal Fixation System

Primary DI
03662663217453
Brand
Vail OCT Spinal Fixation System
Company
Highridge Medical, LLC
Model
7900-3500-020
Catalog number
7900-3500-020
Device description
RS1021378 Set Screw Remover 3.5 mm
Published
2025-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HWBEXTRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663217453PrimaryGS10

GMDN Terms

TermDefinition
Screw extractor, reusableA hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. This is a reusable device.

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
false
Serial number
false
Manufacturing date on label
false
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
10885862648143EquinoxeExactech, Inc.HWB2026-03-19
10885862660466N/AExactech, Inc.HWB2026-03-19
10885862663214N/AExactech, Inc.HWB2026-03-19
B922F00500380ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHWB2026-03-11
00841435122574TecometTECOMET INC.HWB2026-02-27
07899258695174Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695181Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695198Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695204Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695211Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695228Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695235Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
03662663131759Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWB2026-02-11
00840338602497Made-To-OrderTORNIER, INC.HWB2026-02-03
00840338602961Made-To-OrderTORNIER, INC.HWB2026-02-03
00840338607799Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.HWB2026-01-21
00840338607805Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.HWB2026-01-21
00889024704008LB Type 1 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704015LZ 12/14 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704022LB 12/14 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704039Fitmore Extraction Adapter - MZimmer, Inc.HWB2025-12-18
00889024704046Fitmore Extraction Adapter - FZimmer, Inc.HWB2025-12-18
03662663274128Timberline Lateral Fusion SystemHighridge Medical, LLCHWB2025-12-18
03662663217415Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217439Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217446Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217460Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663279277Timberline Lateral Fusion SystemHighridge Medical, LLCHWB2025-12-16
10603295505044ATTUNEDEPUY (IRELAND)HWB2025-12-11
10603295505051ATTUNEDEPUY (IRELAND)HWB2025-12-11