FDA.reportPublic FDA data

ZAVATION INSTRUMENT TRAY

Primary DI
00197157068356
Brand
ZAVATION INSTRUMENT TRAY
Company
Zavation LLC
Model
14T00916
Device description
ZV F3D CURVED INSTRUMENT - 0/6/12 DEG TRIAL TRAY
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162496000Foundation 3D InterbodyCorelink, LLC2017-05-04ODP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157068356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157068356001971570683561971570683560197157068356

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
6019191119info@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
00197157118280ZAVATION SCREW1011-O-095105-S-C2026-10-01
00197157118297ZAVATION SCREW1011-O-095110-S-C2026-10-01
00197157118303ZAVATION SCREW1011-O-095025-S-S2026-10-01
00197157118310ZAVATION SCREW1011-O-095030-S-S2026-10-01
00197157118327ZAVATION SCREW1011-O-095035-S-S2026-10-01
00197157118334ZAVATION SCREW1011-O-095040-S-S2026-10-01
00197157118341ZAVATION SCREW1011-O-095045-S-S2026-10-01
00197157118358ZAVATION SCREW1011-O-095050-S-S2026-10-01
00197157118365ZAVATION SCREW1011-O-095055-S-S2026-10-01
00197157118372ZAVATION SCREW1011-O-095060-S-S2026-10-01
00197157118389ZAVATION SCREW1011-O-095065-S-S2026-10-01
00197157118396ZAVATION SCREW1011-O-095070-S-S2026-10-01
00197157118402ZAVATION SCREW1011-O-095075-S-S2026-10-01
00197157118419ZAVATION SCREW1011-O-095080-S-S2026-10-01
00197157118426ZAVATION SCREW1011-O-095085-S-S2026-10-01
00197157118433ZAVATION SCREW1011-O-095090-S-S2026-10-01
00197157118440ZAVATION SCREW1011-O-095095-S-S2026-10-01
00197157118457ZAVATION SCREW1011-O-095100-S-S2026-10-01
00197157118464ZAVATION SCREW1011-O-095105-S-S2026-10-01
00197157118471ZAVATION SCREW1011-O-095110-S-S2026-10-01

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
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMAX2018-04-16
10888857223769CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217577CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217584CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217591CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217669CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19