FDA.reportPublic FDA data

Zavation Inserter Graft Pusher

Primary DI
00197157019600
Brand
Zavation Inserter Graft Pusher
Company
Zavation LLC
Model
ZAV-1356
Device description
Custom Inserter Graft Pusher
Published
2024-09-04
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
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

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
00197157019600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157019600001971570196001971570196000197157019600

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic graft inserter, reusableA hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a variety of designs, such as a plunger made of high-grade materials [e.g., stainless steel or titanium (Ti)] used to advance the graft down its tubular-shaped holder or possibly a bone graft funnel and into place; it is also available in a variety of sizes. 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
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
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.ODP2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.MAX2026-09-22
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
10888857461819CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCODP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMAX2019-10-31
04546540665720AVS NAVIGATORStryker CorporationMAX2016-09-24
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857218772CASCADIA™ Interbody SystemVB Spine LLCODP2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCODP2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCODP2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCODP2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCODP2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMAX2015-12-16
07613153046196AVS PLStryker CorporationMAX2015-09-14