FDA.reportPublic FDA data

ZAVATION INSERTER

Primary DI
00197157081324
Brand
ZAVATION INSERTER
Company
Zavation LLC
Model
ZAV-1407
Device description
CUSTOM CORPECTOMY CAGE INSERTER
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
00197157081324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157081324001971570813241971570813240197157081324

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic inorganic implant inserter/extractor, reusableA hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. 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
00197157082031ZAVATION SCREW35045-302026-06-05
00197157082048ZAVATION SCREW35045-322026-06-05
00197157082055ZAVATION SCREW35045-342026-06-05
00197157082062ZAVATION SCREW35045-362026-06-05
00197157082079ZAVATION SCREW35045-382026-06-05
00197157082086ZAVATION SCREW35045-402026-06-05
00197157082093ZAVATION SCREW35045-422026-06-05
00197157082109ZAVATION SCREW35045-442026-06-05
00197157082116ZAVATION SCREW35045-462026-06-05
00197157082123ZAVATION SCREW35045-482026-06-05
00197157081515ZAVATION SCREW35035-102026-06-04
00197157081522ZAVATION SCREW35035-122026-06-04
00197157081539ZAVATION SCREW35035-142026-06-04
00197157081546ZAVATION SCREW35035-162026-06-04
00197157081553ZAVATION SCREW35035-182026-06-04
00197157081560ZAVATION SCREW35035-202026-06-04
00197157081577ZAVATION SCREW35035-222026-06-04
00197157081584ZAVATION SCREW35035-242026-06-04
00197157081591ZAVATION SCREW35035-262026-06-04
00197157081607ZAVATION SCREW35035-282026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000857820T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.PLR2026-06-26
00763000857820T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-26
00763000858001T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.PLR2026-06-26
00763000858001T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-26
00840283403460LumiVy™VY SPINE LLCMQP2026-06-05
00763000857844T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.PLR2026-06-01
00763000857844T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00763000857943T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.PLR2026-06-01
00763000857943T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00763000857998T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.PLR2026-06-01
00763000857998T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
00841732128231VALEO VBRCTL Medical CorporationMQP2023-09-27
00841732128248VALEO VBRCTL Medical CorporationMQP2023-09-27
07640164847405KONG-TL VBR E, Expandable Body, Standalone, XXS, Ø 19 mm x 19 - 23 mmicotec AGPLR2020-06-19
07640164847412KONG-TL VBR E, Expandable Body, Standalone, XS, Ø 19 mm x 22 - 29 mmicotec AGPLR2020-06-19
07640164847429KONG-TL VBR E, Expandable Body, S, Ø 19 mm x 20 - 24 mmicotec AGPLR2020-06-19
07640164847436KONG-TL VBR E, Expandable Body, M, Ø 19 mm x 23 - 30 mmicotec AGPLR2020-06-19
07640164847443KONG-TL VBR E, Expandable Body, L, Ø 19 mm x 27 - 37 mmicotec AGPLR2020-06-19
07640164847450KONG-TL VBR E, Expandable Body, XL, Ø 19 mm x 33 - 49 mmicotec AGPLR2020-06-19
07640164847467KONG-TL VBR, Extension, S and Screw, Ø 19 mm x 20 mmicotec AGPLR2020-06-19
07640164847474KONG-TL VBR, Extension, M and Screw, Ø 19 mm x 35 mmicotec AGPLR2020-06-19
07640164847481KONG-TL VBR, Screw, M8 x 6.0 mmicotec AGPLR2020-06-19
07640164847498KONG-TL VBR, End Plate, round, S and Screw, 0° x 26 mmicotec AGPLR2020-06-19
07640164847504KONG-TL VBR, End Plate, round, M and Screw, 0° x 33 mmicotec AGPLR2020-06-19
07640164847511KONG-TL VBR, End Plate, round, L and Screw, 0° x 43 mmicotec AGPLR2020-06-19
07640164847528KONG-TL VBR, End Plate, round, S and Screw, 4° x 26 mmicotec AGPLR2020-06-19
07640164847535KONG-TL VBR, End Plate, round, M and Screw, 4° x 33 mmicotec AGPLR2020-06-19
07640164847542KONG-TL VBR, End Plate, round, L and Screw, 4° x 43 mmicotec AGPLR2020-06-19
07640164847559KONG-TL VBR, End Plate, round, S and Screw, 8° x 26 mmicotec AGPLR2020-06-19
07640164847566KONG-TL VBR, End Plate, round, M and Screw, 8° x 33 mmicotec AGPLR2020-06-19