FDA.reportPublic FDA data

MESA® Spinal System

Primary DI
10888857136113
Brand
MESA® Spinal System
Company
VB Spine LLC
Model
801-06540
Catalog number
801-06540
Device description
Polyaxial Screw Size Ø6.5x40 mm
Published
2015-09-24
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
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
MNHOrthosis, spondylolisthesis spinal fixation
MNIORTHOSIS, SPINAL PEDICLE FIXATION
NKBOrthosis, spinal pedicle fixation, for degenerative disc disease
OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857136113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885713611310888857136113

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
Length40Millimeter
Outer Diameter6.5Millimeter

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
07613153045670XIA IStryker CorporationNKB2014-12-08
07613153045670XIA IStryker CorporationKWQ2014-12-08
07613153045670XIA IStryker CorporationKWP2014-12-08
07613153045670XIA IStryker CorporationMNH2014-12-08
07613153045700XIA IStryker CorporationMNI2014-12-08
07613153045700XIA IStryker CorporationMNH2014-12-08
07613153045700XIA IStryker CorporationKWQ2014-12-08
07613153045700XIA IStryker CorporationKWP2014-12-08
07613153045717XIA IStryker CorporationMNI2014-12-08
07613153045717XIA IStryker CorporationMNH2014-12-08
07613153045717XIA IStryker CorporationNKB2014-12-08
07613153045717XIA IStryker CorporationKWP2014-12-08
07613153045724XIA IStryker CorporationKWQ2014-12-08
07613153045724XIA IStryker CorporationMNI2014-12-08
07613153045724XIA IStryker CorporationNKB2014-12-08
07613153045724XIA IStryker CorporationKWP2014-12-08
07613153045731XIA IStryker CorporationKWP2014-12-08
07613153045731XIA IStryker CorporationKWQ2014-12-08
07613153045731XIA IStryker CorporationMNH2014-12-08
07613153045731XIA IStryker CorporationMNI2014-12-08
07613153045748XIA IStryker CorporationNKB2014-12-08
07613153045748XIA IStryker CorporationMNH2014-12-08
07613153045748XIA IStryker CorporationKWQ2014-12-08
07613153045748XIA IStryker CorporationMNI2014-12-08
07613153045755XIA IStryker CorporationNKB2014-12-08
07613153045755XIA IStryker CorporationMNH2014-12-08
07613153045755XIA IStryker CorporationKWP2014-12-08
07613153045755XIA IStryker CorporationKWQ2014-12-08
07613153045762XIA IIStryker CorporationKWQ2014-12-08
07613153045762XIA IIStryker CorporationKWP2014-12-08