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
00197157122515ZAVATION SCREW1010-C-065060-S-C2026-10-19
00197157122522ZAVATION SCREW1010-C-065065-S-C2026-10-19
00197157122539ZAVATION SCREW1010-C-065070-S-C2026-10-19
00197157122546ZAVATION SCREW1010-C-065075-S-C2026-10-19
00197157122553ZAVATION SCREW1010-C-065080-S-C2026-10-19
00197157122560ZAVATION SCREW1010-C-065085-S-C2026-10-19
00197157122577ZAVATION SCREW1010-C-065090-S-C2026-10-19
00197157122584ZAVATION SCREW1010-C-065095-S-C2026-10-19
00197157122591ZAVATION SCREW1010-C-065100-S-C2026-10-19
00197157122607ZAVATION SCREW1010-C-065105-S-C2026-10-19
00197157122614ZAVATION SCREW1010-C-065110-S-C2026-10-19
00197157122621ZAVATION SCREW1010-C-065025-S-S2026-10-19
00197157122638ZAVATION SCREW1010-C-065030-S-S2026-10-19
00197157122645ZAVATION SCREW1010-C-065035-S-S2026-10-19
00197157122652ZAVATION SCREW1010-C-065040-S-S2026-10-19
00197157122669ZAVATION SCREW1010-C-065045-S-S2026-10-19
00197157122676ZAVATION SCREW1010-C-065050-S-S2026-10-19
00197157122683ZAVATION SCREW1010-C-065055-S-S2026-10-19
00197157122690ZAVATION SCREW1010-C-065060-S-S2026-10-19
00197157122706ZAVATION SCREW1010-C-065065-S-S2026-10-19

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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