FDA.reportPublic FDA data

ZAVATION DISTRACTOR

Primary DI
00197157076061
Brand
ZAVATION DISTRACTOR
Company
Zavation LLC
Model
ZAV-1395-15
Device description
"Custom 7° Paddle Distracter"
Published
2026-05-28
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

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
K191339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191339000Zavation eZspand Interbody SystemZavation Medical Products, LLC2019-08-19MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157076061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157076061001971570760611971570760610197157076061

GMDN Terms#

Term, Definition table
TermDefinition
Spinal intraoperative positioning/manipulation pin, reusableA nonimplantable rod with an external cylindrical and/or polygonal drive intended to be temporarily introduced, with a dedicated tool (not included), into vertebral bone to: 1) assist with positioning of an implantable device; and/or 2) interface with a surgical instrument (e.g., fixation plate, distractor/retractor) during spinal surgery. It may be threaded, however as a pin it is designed such that a significant length protrudes from vertebral bone once introduced (i.e., not a positioning screw). 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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197157075989ZAVATION DISTRACTORZAV-1395-072026-05-28
00197157075996ZAVATION DISTRACTORZAV-1395-082026-05-28
00197157076009ZAVATION DISTRACTORZAV-1395-092026-05-28
00197157076016ZAVATION DISTRACTORZAV-1395-102026-05-28
00197157076023ZAVATION DISTRACTORZAV-1395-112026-05-28
00197157076030ZAVATION DISTRACTORZAV-1395-122026-05-28
00197157076047ZAVATION DISTRACTORZAV-1395-132026-05-28
00197157076054ZAVATION DISTRACTORZAV-1395-142026-05-28
00197157075835ZAVATION DRIVERZAV-13982026-05-27
00197157075842ZAVATION K-WIREZAV-13972026-05-27
00197157075859ZAVATION INSERTERZAV-10552026-05-27
00197157068332ZAVATION INSTRUMENT TRAY14T009142026-05-20
00197157068349ZAVATION INSTRUMENT TRAY14T009152026-05-20
00197157068356ZAVATION INSTRUMENT TRAY14T009162026-05-20
00197157068363ZAVATION INSTRUMENT TRAY14T009172026-05-20
00197157068370ZAVATION INSTRUMENT TRAY14T009192026-05-20
00197157068387ZAVATION INSTRUMENT TRAY14T009202026-05-20
00197157068394ZAVATION INSTRUMENT TRAY14T009212026-05-20
00197157068400ZAVATION INSTRUMENT TRAY14T009222026-05-20
00197157068417ZAVATION INSTRUMENT TRAY14T009242026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075989ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157075996ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157076009ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157076016ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157076023ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157076030ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157076047ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157076054ZAVATION DISTRACTORZavation LLCMAX2026-05-28
00197157075859ZAVATION INSERTERZavation LLCMAX2026-05-27
00810166522366X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
00810166522373X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
B70712535005S0Dual X Graft Tamp ShortAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010130DUALXS T/PLIF 15 DEG x 9-12MMAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010200DUALXS T/PLIF 18 DEG x 10-13MMAMPLIFY SURGICAL, INC.MAX2026-05-27
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07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046356AVS PLStryker CorporationMAX2015-09-14
07613153046363AVS PLStryker CorporationMAX2015-09-14
07613153046394AVS TLStryker CorporationMAX2015-09-14
07613153046400AVS TLStryker CorporationMAX2015-09-14
07613153046417AVS TLStryker CorporationMAX2015-09-14
07613153046424AVS TLStryker CorporationMAX2015-09-14
07613153046431AVS TLStryker CorporationMAX2015-09-14
07613153046448AVS TLStryker CorporationMAX2015-09-14
07613153046455AVS TLStryker CorporationMAX2015-09-14