FDA.reportPublic FDA data

Palo Alto ™

Primary DI
00852587007732
Brand
Palo Alto ™
Company
CARDINAL SPINE LLC
Model
LCM 23.25 MM
Catalog number
LCM 23.25 MM
Device description
CVBR LCM 23.25 MM
Published
2017-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLRSpinal vertebral body replacement device - Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLRSpinal Vertebral Body Replacement Device - CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152568000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152568000C-VBRCardinal Spine, LLC2016-02-11PLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852587007732PrimaryGS10
10888857386266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852587007732008525870077328525870077320852587007732
1088885738626610888857386266

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesis, non-sterileA non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle9degree
Depth12Millimeter
Device Size Text, specify0
Height23.25Millimeter
Length12Millimeter
Width13Millimeter
Width14Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(502)245-5767cardinalspinellc@gmail.com
+1(571)919-2000mark.zellers@stryker.com

Regulatory Flags#

DUNS number
009915751
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000857851T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.PLR2026-10-11
00763000857950T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.PLR2026-10-11
10888857160460CASCADIA™ Interbody SystemVB Spine LLCPLR2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCPLR2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCPLR2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCPLR2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCPLR2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCPLR2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCPLR2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCPLR2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCPLR2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCPLR2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCPLR2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCPLR2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCPLR2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19