FDA.reportPublic FDA data

ALEUTIAN® Interbody Systems

Primary DI
10888857116634
Brand
ALEUTIAN® Interbody Systems
Company
VB Spine LLC
Model
602-90355
Catalog number
602-90355
Device description
Convex Trial, Size 10x28x11 mm
Published
2016-09-16
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
MAXIntervertebral fusion device with bone graft, lumbar
MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857116634PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885711663410888857116634

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0
Length0
Width0

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
false
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
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.MAX2026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.ODP2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMAX2018-04-16
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMQP2018-04-16
10888857160460CASCADIA™ Interbody SystemVB Spine LLCODP2018-04-16
10888857161061CASCADIA™ Interbody SystemVB Spine LLCMQP2016-09-02
10888857161061CASCADIA™ Interbody SystemVB Spine LLCMAX2016-09-02
10888857161061CASCADIA™ Interbody SystemVB Spine LLCODP2016-09-02
10888857161078CASCADIA™ Interbody SystemVB Spine LLCMQP2016-09-02
10888857161078CASCADIA™ Interbody SystemVB Spine LLCODP2016-09-02
10888857161078CASCADIA™ Interbody SystemVB Spine LLCMAX2016-09-02
10888857161085CASCADIA™ Interbody SystemVB Spine LLCODP2016-09-02
10888857161085CASCADIA™ Interbody SystemVB Spine LLCMQP2016-09-02
10888857161085CASCADIA™ Interbody SystemVB Spine LLCMAX2016-09-02
10888857161092CASCADIA™ Interbody SystemVB Spine LLCODP2016-09-02
10888857161092CASCADIA™ Interbody SystemVB Spine LLCMAX2016-09-02
10888857161092CASCADIA™ Interbody SystemVB Spine LLCMQP2016-09-02
10888857161108CASCADIA™ Interbody SystemVB Spine LLCODP2016-09-02
10888857161108CASCADIA™ Interbody SystemVB Spine LLCMAX2016-09-02
10888857161108CASCADIA™ Interbody SystemVB Spine LLCMQP2016-09-02
10888857161115CASCADIA™ Interbody SystemVB Spine LLCODP2016-09-02
10888857161115CASCADIA™ Interbody SystemVB Spine LLCMAX2016-09-02
10888857161115CASCADIA™ Interbody SystemVB Spine LLCMQP2016-09-02
10888857161122CASCADIA™ Interbody SystemVB Spine LLCODP2016-09-02
10888857161122CASCADIA™ Interbody SystemVB Spine LLCMAX2016-09-02
10888857161122CASCADIA™ Interbody SystemVB Spine LLCMQP2016-09-02
10888857161290CASCADIA™ Interbody SystemVB Spine LLCMQP2016-09-02
10888857161290CASCADIA™ Interbody SystemVB Spine LLCMAX2016-09-02
10888857161290CASCADIA™ Interbody SystemVB Spine LLCODP2016-09-02
10888857161306CASCADIA™ Interbody SystemVB Spine LLCMQP2016-09-02