FDA.reportPublic FDA data

ZAVATION CUSTOM

Primary DI
00197157081331
Brand
ZAVATION CUSTOM
Company
Zavation LLC
Model
ZAV-1408
Device description
CUSTOM TORQUE SHAFT – T8
Published
2026-05-08
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
MQPSpinal Vertebral Body Replacement Device
PLRSpinal Vertebral Body Replacement Device - Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
PLRSpinal Vertebral Body Replacement Device - CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180673000Normandy VBR SystemZavation Medical Products, LLC2018-07-13PLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197157081331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157081331001971570813311971570813310197157081331

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic counter-torque/rod-pushing instrumentA hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. 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
00197157122874ZAVATION SCREW1010-C-065060-C-C2026-10-20
00197157122881ZAVATION SCREW1010-C-065065-C-C2026-10-20
00197157122898ZAVATION SCREW1010-C-065070-C-C2026-10-20
00197157122904ZAVATION SCREW1010-C-065075-C-C2026-10-20
00197157122911ZAVATION SCREW1010-C-065080-C-C2026-10-20
00197157122928ZAVATION SCREW1010-C-065085-C-C2026-10-20
00197157122935ZAVATION SCREW1010-C-065090-C-C2026-10-20
00197157122942ZAVATION SCREW1010-C-065095-C-C2026-10-20
00197157122959ZAVATION SCREW1010-C-065100-C-C2026-10-20
00197157122966ZAVATION SCREW1010-C-065105-C-C2026-10-20
00197157122973ZAVATION SCREW1010-C-065110-C-C2026-10-20
00197157122980ZAVATION SCREW1010-C-065025-C-S2026-10-20
00197157122997ZAVATION SCREW1010-C-065030-C-S2026-10-20
00197157123000ZAVATION SCREW1010-C-065035-C-S2026-10-20
00197157123017ZAVATION SCREW1010-C-065040-C-S2026-10-20
00197157123024ZAVATION SCREW1010-C-065045-C-S2026-10-20
00197157123031ZAVATION SCREW1010-C-065050-C-S2026-10-20
00197157123048ZAVATION SCREW1010-C-065055-C-S2026-10-20
00197157123055ZAVATION SCREW1010-C-065060-C-S2026-10-20
00197157123062ZAVATION SCREW1010-C-065065-C-S2026-10-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000857851T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-10-11
00763000857851T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.PLR2026-10-11
00763000857950T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.PLR2026-10-11
00763000857950T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-10-11
10888857160460CASCADIA™ Interbody SystemVB Spine LLCPLR2018-04-16
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMQP2018-04-16
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217355CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217461CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217478CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217485CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217492CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19
10888857217553CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCPLR2017-07-19
10888857217560CASCADIA™ Interbody SystemVB Spine LLCMQP2017-07-19