FDA.reportPublic FDA data

ZAVATION CADDY

Primary DI
00197157080839
Brand
ZAVATION CADDY
Company
Zavation LLC
Model
259-9000-C2
Device description
Normandy Cervical Caddy - 16x14mm Implants
Published
2026-05-12
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
00197157080839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197157080839001971570808391971570808390197157080839

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
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
00197157059521ZAVATION RODR5522-0852026-06-04
00197157059538ZAVATION RODR5522-0902026-06-04
00197157059545ZAVATION RODR5522-0952026-06-04
00197157059552ZAVATION RODR5522-1002026-06-04
00197157059569ZAVATION RODR5522-1052026-06-04
00197157059576ZAVATION RODR5522-1102026-06-04
00197157059583ZAVATION RODR5522-1152026-06-04
00197157059590ZAVATION RODR5522-1202026-06-04
00197157059606ZAVATION RODR5522-1252026-06-04
00197157059613ZAVATION RODR5522-1302026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07640164847870KONG-TL VBR System, KONG-TL VBR E, Container, completeicotec AGPLR2023-09-08
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
07640164847573KONG-TL VBR, End Plate, round, L and Screw, 8° x 43 mmicotec AGPLR2020-06-19
07640164847580KONG-TL VBR, End Plate, round, S and Screw, 12° x 26 mmicotec AGPLR2020-06-19
07640164847597KONG-TL VBR, End Plate, round, M and Screw, 12° x 33 mmicotec AGPLR2020-06-19
07640164847603KONG-TL VBR, End Plate, round, L and Screw, 12° x 43 mmicotec AGPLR2020-06-19
07640164847610KONG-TL VBR, End Plate, rectangular, M and Screw, 0° x 33 mmicotec AGPLR2020-06-19