FDA.reportPublic FDA data

ZAVATION

Primary DI
00842166173545
Brand
ZAVATION
Company
Zavation LLC
Model
563-1007
Device description
LABYRINTH CIF 14mmx18mm , 10deg , 7mm
Published
2022-04-20
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202305000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202305000Zavation IBF SystemZavation Medical Products, LLC2020-10-13MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842166173545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166173545008421661735458421661735450842166173545

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Sterilization Methods#

Method table
Method
Radiation 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
00197157119089ZAVATION SCREW1011-O-095055-F-S2026-10-05
00197157119096ZAVATION SCREW1011-O-095060-F-S2026-10-05
00197157119102ZAVATION SCREW1011-O-095065-F-S2026-10-05
00197157119119ZAVATION SCREW1011-O-095070-F-S2026-10-05
00197157119126ZAVATION SCREW1011-O-095075-F-S2026-10-05
00197157119133ZAVATION SCREW1011-O-095080-F-S2026-10-05
00197157119140ZAVATION SCREW1011-O-095085-F-S2026-10-05
00197157119157ZAVATION SCREW1011-O-095090-F-S2026-10-05
00197157119164ZAVATION SCREW1011-O-095095-F-S2026-10-05
00197157119171ZAVATION SCREW1011-O-095100-F-S2026-10-05
00197157119188ZAVATION SCREW1011-O-095105-F-S2026-10-05
00197157119195ZAVATION SCREW1011-O-095110-F-S2026-10-05
00197157119201ZAVATION SCREW1011-O-105025-S-C2026-10-05
00197157119218ZAVATION SCREW1011-O-105030-S-C2026-10-05
00197157119225ZAVATION SCREW1011-O-105035-S-C2026-10-05
00197157119232ZAVATION SCREW1011-O-105040-S-C2026-10-05
00197157119249ZAVATION SCREW1011-O-105045-S-C2026-10-05
00197157119256ZAVATION SCREW1011-O-105050-S-C2026-10-05
00197157119263ZAVATION SCREW1011-O-105055-S-C2026-10-05
00197157119270ZAVATION SCREW1011-O-105060-S-C2026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.MAX2026-10-01
00810017916214SABER-XA, Anterior Plate, 37Wx13HELEVATION SPINE, INC.ODP2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMAX2018-04-16
10888857160460CASCADIA™ Interbody SystemVB Spine LLCODP2018-04-16
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217355CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCODP2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19