FDA.reportPublic FDA data

Zavation

Primary DI
00842166123007
Brand
Zavation
Company
Zavation LLC
Model
250-1416-44-00
Device description
Cage - 14x16mm, 44-76mm, 0°
Published
2020-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
00842166123007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166123007008421661230078421661230070842166123007

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
601-919-1119info@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