FDA.reportPublic FDA data

Zavation

Primary DI
00842166182554
Brand
Zavation
Company
Zavation LLC
Model
250-9115
Device description
Glove Guard
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
00842166182554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166182554008421661825548421661825540842166182554

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
00197157122874ZAVATION SCREW1010-C-065060-C-C2026-10-20
00197157122881ZAVATION SCREW1010-C-065065-C-C2026-10-20
00197157122898ZAVATION SCREW1010-C-065070-C-C2026-10-20
00197157122904ZAVATION SCREW1010-C-065075-C-C2026-10-20
00197157122911ZAVATION SCREW1010-C-065080-C-C2026-10-20
00197157122928ZAVATION SCREW1010-C-065085-C-C2026-10-20
00197157122935ZAVATION SCREW1010-C-065090-C-C2026-10-20
00197157122942ZAVATION SCREW1010-C-065095-C-C2026-10-20
00197157122959ZAVATION SCREW1010-C-065100-C-C2026-10-20
00197157122966ZAVATION SCREW1010-C-065105-C-C2026-10-20
00197157122973ZAVATION SCREW1010-C-065110-C-C2026-10-20
00197157122980ZAVATION SCREW1010-C-065025-C-S2026-10-20
00197157122997ZAVATION SCREW1010-C-065030-C-S2026-10-20
00197157123000ZAVATION SCREW1010-C-065035-C-S2026-10-20
00197157123017ZAVATION SCREW1010-C-065040-C-S2026-10-20
00197157123024ZAVATION SCREW1010-C-065045-C-S2026-10-20
00197157123031ZAVATION SCREW1010-C-065050-C-S2026-10-20
00197157123048ZAVATION SCREW1010-C-065055-C-S2026-10-20
00197157123055ZAVATION SCREW1010-C-065060-C-S2026-10-20
00197157123062ZAVATION SCREW1010-C-065065-C-S2026-10-20

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