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
00197157117214ZAVATION SCREW1011-O-085110-S-C2026-09-21
00197157117221ZAVATION SCREW1011-O-085025-S-S2026-09-21
00197157117238ZAVATION SCREW1011-O-085030-S-S2026-09-21
00197157117245ZAVATION SCREW1011-O-085035-S-S2026-09-21
00197157117252ZAVATION SCREW1011-O-085040-S-S2026-09-21
00197157117269ZAVATION SCREW1011-O-085045-S-S2026-09-21
00197157117276ZAVATION SCREW1011-O-085050-S-S2026-09-21
00197157117283ZAVATION SCREW1011-O-085055-S-S2026-09-21
00197157117290ZAVATION SCREW1011-O-085060-S-S2026-09-21
00197157117306ZAVATION SCREW1011-O-085065-S-S2026-09-21
00197157117313ZAVATION SCREW1011-O-085070-S-S2026-09-21
00197157117320ZAVATION SCREW1011-O-085075-S-S2026-09-21
00197157117337ZAVATION SCREW1011-O-085080-S-S2026-09-21
00197157117344ZAVATION SCREW1011-O-085085-S-S2026-09-21
00197157117351ZAVATION SCREW1011-O-085090-S-S2026-09-21
00197157117368ZAVATION SCREW1011-O-085095-S-S2026-09-21
00197157117375ZAVATION SCREW1011-O-085100-S-S2026-09-21
00197157117382ZAVATION SCREW1011-O-085105-S-S2026-09-21
00197157117399ZAVATION SCREW1011-O-085110-S-S2026-09-21
00197157117405ZAVATION SCREW1011-O-085025-C-C2026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606185110LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185127LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185134LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185141LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185158LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606185165LUNA TiSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196024VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196031VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00840606196048VertuSPINAL ELEMENTS, INC.MAX2026-09-25
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
04546540665720AVS NAVIGATORStryker CorporationMAX2016-09-24
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046226AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046288AVS PLStryker CorporationMAX2015-09-14
07613153046295AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046318AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046349AVS PLStryker CorporationMAX2015-09-14