FDA.reportPublic FDA data

ALEUTIAN® Interbody Systems

Primary DI
10888857521971
Brand
ALEUTIAN® Interbody Systems
Company
VB Spine LLC
Model
SP-4214-73
Catalog number
SP-4214-73
Device description
Trial Size 12x14x12 mm, Convex
Published
2021-04-26
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
10888857521971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885752197110888857521971

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0
Device Size Text, specify0
Height0
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606185110LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185127LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185134LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMQP2019-10-31
10888857461819CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMQP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
04546540665720AVS NAVIGATORStryker CorporationMAX2016-09-24
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857218772CASCADIA™ Interbody SystemVB Spine LLCODP2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCODP2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCODP2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16