FDA.reportPublic FDA data

Vulcan™ Spinal System

Primary DI
10888857578142
Brand
Vulcan™ Spinal System
Company
VB Spine LLC
Model
8042-90253
Catalog number
8042-90253
Device description
Screwdriver Sleeve, Short
Published
2026-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857578142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885757814210888857578142

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(571)919-2000mark.zellers@stryker.com

Regulatory Flags#

DUNS number
119508156
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888857615694CHESAPEAKE® Stabilization SystemPRO-1436-02PRO-1436-022026-09-23
10888857615724OZARK Cervical Plate SystemPRO-1445PRO-14452026-09-22
10888857613805Xia® 3PRO-1438PRO-14382026-06-11
10888857613812K2M General InstrumentsPRO-1439PRO-14392026-06-12
10888857599710YUKON OCT Spinal SystemPRO-1435PRO-14352026-08-25
10888857598256Xia® 3 System - Serrato®482614535V482614535V2026-07-24
10888857598263Xia® 3 System - Serrato®482614540V482614540V2026-07-24
10888857598270Xia® 3 System - Serrato®482614545V482614545V2026-07-24
10888857598287Xia® 3 System - Serrato®482615020V482615020V2026-07-24
10888857598294Xia® 3 System - Serrato®482615025V482615025V2026-07-24
10888857598300Xia® 3 System - Serrato®482615030V482615030V2026-07-24
10888857598317Xia® 3 System - Serrato®482615035V482615035V2026-07-24
10888857598324Xia® 3 System - Serrato®482615040V482615040V2026-07-24
10888857598331Xia® 3 System - Serrato®482615045V482615045V2026-07-24
10888857598348Xia® 3 System - Serrato®482615050V482615050V2026-07-24
10888857598355Xia® 3 System - Serrato®482615525V482615525V2026-07-24
10888857598362Xia® 3 System - Serrato®482615530V482615530V2026-07-24
10888857598379Xia® 3 System - Serrato®482615535V482615535V2026-07-24
10888857598386Xia® 3 System - Serrato®482615540V482615540V2026-07-24
10888857598393Xia® 3 System - Serrato®482615545V482615545V2026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00810111227872PinTreace Medical Concepts, Inc.HWE2026-10-16
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-15
00810111228541Drill TackTreace Medical Concepts, Inc.HWE2026-10-15
00810111227971PinTreace Medical Concepts, Inc.HWE2026-10-12
00810111227988PinTreace Medical Concepts, Inc.HWE2026-10-12
03700879515687Airlock®NOVASTEPHWE2026-08-25
08800038061286EZXIMEDICOM CO., LTD.HWE2026-08-25
00850083430108SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00850083430122SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00850083430139SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWE2026-08-17
00193982616472ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.HWE2026-08-14
00193982616489ORTHOPEDIC MANUAL SURGICAL INSTRUMENTGLOBUS MEDICAL, INC.HWE2026-08-14
10888857596719Xia® 3VB Spine LLCHWE2026-05-12
10888857596726Xia® 3VB Spine LLCHWE2026-05-12
10888857596733Xia® 3VB Spine LLCHWE2026-05-12
10888857578135Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578159Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578166Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578210Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578227Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578234Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578241Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578760Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578784Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578807Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578821Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578845Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20
10888857578852Vulcan™ Spinal SystemVB Spine LLCHWE2026-02-20