FDA.reportPublic FDA data

Xia® 3

Primary DI
10888857596719
Brand
Xia® 3
Company
VB Spine LLC
Model
PRO-1432-01
Catalog number
PRO-1432-01
Device description
PRO-1432-01
Published
2026-05-12
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
10888857596719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885759671910888857596719

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)919-2000alex.lopez@vbspineco.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
10888857598164Xia® 3 System - Serrato®482614020V482614020V2026-07-24
10888857598171Xia® 3 System - Serrato®482614025V482614025V2026-07-24
10888857598188Xia® 3 System - Serrato®482614030V482614030V2026-07-24
10888857598195Xia® 3 System - Serrato®482614035V482614035V2026-07-24
10888857598201Xia® 3 System - Serrato®482614040V482614040V2026-07-24
10888857598218Xia® 3 System - Serrato®482614045V482614045V2026-07-24
10888857598225Xia® 3 System - Serrato®482614520V482614520V2026-07-24
10888857598232Xia® 3 System - Serrato®482614525V482614525V2026-07-24
10888857598249Xia® 3 System - Serrato®482614530V482614530V2026-07-24
10888857082588CHESAPEAKE Stabilization System3608-900343608-900342022-06-01
10888857461819CASCADIA™ Interbody System6101-2852209NL6-G26101-2852209NL6-G22019-10-31
10888857461888CASCADIA™ Interbody System6101-2852205NL12-G26101-2852205NL12-G22019-10-31
10888857218772CASCADIA™ Interbody System6101-2225008LP-G26101-2225008LP-G22015-12-16
10888857218963CASCADIA™ Interbody System6101-2224512LP-G26101-2224512LP-G22015-12-16
10888857219076CASCADIA™ Interbody System6101-2225014LP-G26101-2225014LP-G22015-12-16
10888857219489CASCADIA™ Interbody System6101-2225508LL8-G26101-2225508LL8-G22015-12-16
10888857219595CASCADIA™ Interbody System6101-2226010LL8-G26101-2226010LL8-G22015-12-16
10888857252820DENALI® Spinal System1301-900391301-900392026-08-28
10888857615724OZARK Cervical Plate SystemPRO-1445PRO-14452026-09-22
10888857037953EVEREST® Spinal System2901-5601002901-5601002026-06-11

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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
03701089527897AMPLITUDEAMPLITUDE SASHWE2026-07-29
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00841731153173ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153180ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153197ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153203ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153210ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153227ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153234ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153241ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
03700879515540airlock®NOVASTEPHWE2026-07-10
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-06-28
04589551366217P300-2A100NAKANISHI INC.HWE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HWE2026-06-26
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04589551366422PD-IN-2-120NAKANISHI INC.HWE2026-06-26
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