FDA.reportPublic FDA data

ZAVATION STANDARD BASE

Primary DI
00197157072919
Brand
ZAVATION STANDARD BASE
Company
Zavation LLC
Model
14T00931
Device description
ZAVATION NORMANDY LUMBAR STANDARD BASE
Published
2025-09-16
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
00197157072919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157072919001971570729191971570729190197157072919

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. 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
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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
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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
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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
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