FDA.reportPublic FDA data

VERTEX® Reconstruction System

Primary DI
00643169202665
Brand
VERTEX® Reconstruction System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7753884L
Device description
CADDY LID 7753884L CERVICAL THORACIC
Published
2021-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190840000Medtronic Transportation / Sterilization CassettesMedtronic Sofamor Danek USA, Inc.2019-10-15KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169202665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169202665006431692026656431692026650643169202665

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical 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 may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150073504Medtronic Reusable InstrumentsEX12250012026-05-25
00199150071685Medtronic Reusable InstrumentsEX02261402026-05-24
00199150071692Medtronic Reusable InstrumentsEX02261502026-05-24
00199150071708Medtronic Reusable InstrumentsEX02261602026-05-24
00199150071715Medtronic Reusable InstrumentsEX02261702026-05-24
00199150071722Medtronic Reusable InstrumentsEX02261802026-05-24
00199150071739Medtronic Reusable InstrumentsEX02261902026-05-24
00199150071746Medtronic Reusable InstrumentsEX02262002026-05-24
00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24
00199150071784Medtronic Reusable InstrumentsEX02260702026-05-24
00199150071791Medtronic Reusable InstrumentsEX02260802026-05-24
00199150071807Medtronic Reusable InstrumentsEX02260902026-05-24
00199150071814Medtronic Reusable InstrumentsEX02261002026-05-24
00199150072057Medtronic Reusable InstrumentsX65500232026-05-23
00199150072064Medtronic Reusable InstrumentsX65500242026-05-23
00199150072576Medtronic Reusable InstrumentsEX02260222026-05-23
00199150074532Medtronic Reusable InstrumentsX12250022026-05-22
00199150074549Medtronic Reusable InstrumentsX12250032026-05-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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ESAM23080001STOMA®Storz am Mark GmbHFSM2025-04-30
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ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
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EZPF85140000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85142100HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
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EZPF85145000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85150000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85195650HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85312070HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85180000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180020HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180030HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180040HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180050HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180100HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181030HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181040HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181050HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181090HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85182000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09