FDA.report

Zavation

Primary DI
00842166187900
Brand
Zavation
Company
ZAVATION LLC
Model
ZAV-1197-12
Device description
Distractor
Published
2020-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications

CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842166187900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166187900008421661879008421661879000842166187900

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
601-919-1119info@zavation.com

Regulatory Flags

DUNS number
069472800
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00197157071400ZAVATION ROD BENDER989-1065-R 2025-09-15
00197157071417ZAVATION ROD BENDER989-1065-L 2025-09-15
00197157071455ZAVATION CADDY1010-9002-12025-09-15
00197157071462ZAVATION CADDY1010-9002-22025-09-15
00197157071479ZAVATION CADDY1010-9002-32025-09-15
00197157071486ZAVATION CADDY1010-9002-42025-09-15
00197157071493ZAVATION CADDY1010-9002-52025-09-15
00197157071509ZAVATION CADDY LID1010-9002-62025-09-15
00197157071516ZAVATION CADDY LID1010-9002-72025-09-15
00197157071523ZAVATION CADDY 1010-9002-82025-09-15
00197157071530ZAVATION CADDY LID1010-9002-92025-09-15
00197157071547ZAVATION CADDY LID1010-9002-102025-09-15
00197157071585ZAVATION RODR5509-0352025-09-15
00197157071592ZAVATION RODR5509-0402025-09-15
00197157071608ZAVATION RODR5509-0452025-09-15
00197157071615ZAVATION RODR5509-0502025-09-15
00197157071622ZAVATION RODR5509-0552025-09-15
00197157071639ZAVATION RODR5509-0602025-09-15
00197157071646ZAVATION RODR5509-0652025-09-15
00197157071653ZAVATION RODR5509-0702025-09-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00763000887131CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887162CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887179CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
088000333582064CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2020-03-26
088000333846944CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847174CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847244CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847484CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847554CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847624CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847794CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847864CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333850974CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-12-11
088000333851104CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-12-11
088000333859984CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860184CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860494CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860564CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860634CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860704CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860874CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860944CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861004CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861174CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861244CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861314CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861484CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861624CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861794CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861864CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24