FDA.reportPublic FDA data

EVEREST® Spinal System

Primary DI
10888857043374
Brand
EVEREST® Spinal System
Company
VB Spine LLC
Model
2911-09530
Catalog number
2911-09530
Device description
Sacroiliac Screw Size Ø9.5x30 mm
Published
2016-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857043374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885704337410888857043374

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Millimeter
Outer Diameter9.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(703)777-3155mzellers@k2m.com
+1(571)919-2000mark.zellers@stryker.com

Regulatory Flags#

DUNS number
119508156
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888857596719Xia® 3PRO-1432-01PRO-1432-012026-05-12
10888857596726Xia® 3PRO-1432-02PRO-1432-022026-05-12
10888857596733Xia® 3PRO-1432-03PRO-1432-032026-05-12
10888857219656CASCADIA™ Interbody System6101-2224012LL8-G26101-2224012LL8-G22016-12-30
10888857219793CASCADIA™ Interbody System6101-2226014LL8-G26101-2226014LL8-G22015-12-16
10888857220966CASCADIA™ Interbody System6101-2224510LL12-G26101-2224510LL12-G22016-12-30
10888857221093CASCADIA™ Interbody System6101-2226012LL12-G26101-2226012LL12-G22016-12-30
10888857221871CASCADIA™ Interbody System6101-2225014LL15-G26101-2225014LL15-G22016-12-30
10888857221895CASCADIA™ Interbody System6101-2226014LL15-G26101-2226014LL15-G22016-12-30
10888857346420CANYON™ Retractor Systems6401-901076401-901072020-06-18
10888857035553RAVINE® Lateral Access System2701-900722701-900722022-02-14
10888857596900OZARK Cervical Plate SystemPRO-1427-10PRO-1427-102026-05-01
10888857596917OZARK Cervical Plate SystemPRO-1427-12PRO-1427-122026-05-01
10888857596924OZARK Cervical Plate SystemPRO-1427-14PRO-1427-142026-05-01
10888857596931OZARK Cervical Plate SystemPRO-1427-16PRO-1427-162026-05-01
10888857596948OZARK Cervical Plate SystemPRO-1427-18PRO-1427-182026-05-01
10888857218765CASCADIA™ Interbody System6101-2224508LP-G26101-2224508LP-G22015-12-16
10888857218888CASCADIA™ Interbody System6101-2225510LP-G26101-2225510LP-G22015-12-16
10888857218895CASCADIA™ Interbody System6101-2226010LP-G26101-2226010LP-G22015-12-16
10888857219489CASCADIA™ Interbody System6101-2225508LL8-G26101-2225508LL8-G22015-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613153143734XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143734XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613153143734XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationKWP2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143741XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143758XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143758XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNI2015-09-14
07613153143765XIA STAINLESS STEELStryker CorporationMNH2015-09-14
07613153045670XIA IStryker CorporationKWP2014-12-08
07613153045670XIA IStryker CorporationMNH2014-12-08
07613153045700XIA IStryker CorporationMNI2014-12-08
07613153045700XIA IStryker CorporationMNH2014-12-08
07613153045700XIA IStryker CorporationKWP2014-12-08
07613153045717XIA IStryker CorporationMNI2014-12-08
07613153045717XIA IStryker CorporationMNH2014-12-08
07613153045717XIA IStryker CorporationKWP2014-12-08
07613153045724XIA IStryker CorporationKWP2014-12-08
07613153045724XIA IStryker CorporationMNI2014-12-08
07613153045731XIA IStryker CorporationKWP2014-12-08
07613153045731XIA IStryker CorporationMNH2014-12-08
07613153045731XIA IStryker CorporationMNI2014-12-08
07613153045748XIA IStryker CorporationMNH2014-12-08
07613153045748XIA IStryker CorporationMNI2014-12-08
07613153045755XIA IStryker CorporationKWP2014-12-08
07613153045755XIA IStryker CorporationMNH2014-12-08
07613153045762XIA IIStryker CorporationMNH2014-12-08
07613153045762XIA IIStryker CorporationKWP2014-12-08
07613153045793XIA IIStryker CorporationKWP2014-12-08