FDA.reportPublic FDA data

Zavation Pedicle Marker

Primary DI
00197157048754
Brand
Zavation Pedicle Marker
Company
Zavation LLC
Model
ZAV-1368-2
Device description
Pedicle Marker
Published
2024-10-16
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
KWPAppliance, Fixation, Spinal Interlaminal
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181244000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181244000Zavation Cervical Plate SystemZavation Medical Products, LLC2018-07-10KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157048754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157048754001971570487541971570487540197157048754

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation procedure kit, reusableA collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. 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
00197157113384ZAVATION SCREW1011-O-045085-S-S2026-09-04
00197157113391ZAVATION SCREW1011-O-045090-S-S2026-09-04
00197157113407ZAVATION SCREW1011-O-045095-S-S2026-09-04
00197157113414ZAVATION SCREW1011-O-045100-S-S2026-09-04
00197157113421ZAVATION SCREW1011-O-045105-S-S2026-09-04
00197157113438ZAVATION SCREW1011-O-045110-S-S2026-09-04
00197157113445ZAVATION SCREW1011-O-045025-C-C2026-09-04
00197157113452ZAVATION SCREW1011-O-045030-C-C2026-09-04
00197157113469ZAVATION SCREW1011-O-045035-C-C2026-09-04
00197157113476ZAVATION SCREW1011-O-045040-C-C2026-09-04
00197157113483ZAVATION SCREW1011-O-045045-C-C2026-09-04
00197157113490ZAVATION SCREW1011-O-045050-C-C2026-09-04
00197157113506ZAVATION SCREW1011-O-045055-C-C2026-09-04
00197157113513ZAVATION SCREW1011-O-045060-C-C2026-09-04
00197157113520ZAVATION SCREW1011-O-045065-C-C2026-09-04
00197157113537ZAVATION SCREW1011-O-045070-C-C2026-09-04
00197157113544ZAVATION SCREW1011-O-045075-C-C2026-09-04
00197157113551ZAVATION SCREW1011-O-045080-C-C2026-09-04
00197157113568ZAVATION SCREW1011-O-045085-C-C2026-09-04
00197157113575ZAVATION SCREW1011-O-045090-C-C2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857037953EVEREST® Spinal SystemVB Spine LLCKWP2026-06-11
10888857037953EVEREST® Spinal SystemVB Spine LLCMNI2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCKWP2026-06-11
10888857037977EVEREST® Spinal SystemVB Spine LLCMNI2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001428DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCKWP2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCMNI2018-11-05
10888857008724EVEREST® Spinal SystemVB Spine LLCKWP2016-03-10
10888857008724EVEREST® Spinal SystemVB Spine LLCMNI2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001497DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCMNI2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCKWP2015-09-24