FDA.reportPublic FDA data

ALEUTIAN® Interbody Systems

Primary DI
10888857421080
Brand
ALEUTIAN® Interbody Systems
Company
VB Spine LLC
Model
SP-3140
Catalog number
SP-3140
Device description
Angled Lateral Inserter Size 25°
Published
2018-10-23
Public version status
Update
Distribution status
Not 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
10888857421080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885742108010888857421080

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0

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