FDA.reportPublic FDA data

Zavation

Primary DI
00842166182547
Brand
Zavation
Company
Zavation LLC
Model
250-9112
Device description
Graft Tamp
Published
2020-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSpinal Vertebral Body Replacement Device
PLRSpinal Vertebral Body Replacement Device - Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
PLRSpinal Vertebral Body Replacement Device - CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180673000Normandy VBR SystemZavation Medical Products, LLC2018-07-13PLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842166182547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166182547008421661825478421661825470842166182547

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
601-919-1119info@zavation.com

Regulatory Flags#

DUNS number
069472800
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197157119638ZAVATION SCREW1011-O-105060-C-C2026-10-12
00197157119645ZAVATION SCREW1011-O-105065-C-C2026-10-12
00197157119652ZAVATION SCREW1011-O-105070-C-C2026-10-12
00197157119669ZAVATION SCREW1011-O-105075-C-C2026-10-12
00197157119676ZAVATION SCREW1011-O-105080-C-C2026-10-12
00197157119683ZAVATION SCREW1011-O-105085-C-C2026-10-12
00197157119690ZAVATION SCREW1011-O-105090-C-C2026-10-12
00197157119706ZAVATION SCREW1011-O-105095-C-C2026-10-12
00197157119713ZAVATION SCREW1011-O-105100-C-C2026-10-12
00197157119720ZAVATION SCREW1011-O-105105-C-C2026-10-12
00197157119737ZAVATION SCREW1011-O-105110-C-C2026-10-12
00197157119744ZAVATION SCREW1011-O-105025-C-S2026-10-12
00197157119751ZAVATION SCREW1011-O-105030-C-S2026-10-12
00197157119768ZAVATION SCREW1011-O-105035-C-S2026-10-12
00197157119775ZAVATION SCREW1011-O-105040-C-S2026-10-12
00197157119782ZAVATION SCREW1011-O-105045-C-S2026-10-12
00197157119799ZAVATION SCREW1011-O-105050-C-S2026-10-12
00197157119805ZAVATION SCREW1011-O-105055-C-S2026-10-12
00197157119812ZAVATION SCREW1011-O-105060-C-S2026-10-12
00197157119829ZAVATION SCREW1011-O-105065-C-S2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000857851T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-10-11
00763000857851T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.PLR2026-10-11
00763000857950T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.PLR2026-10-11
00763000857950T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-10-11
10888857160460CASCADIA™ Interbody SystemVB Spine LLCPLR2018-04-16
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMQP2018-04-16
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217355CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19