FDA.reportPublic FDA data

VERTEX® Reconstruction System

Primary DI
00643169474888
Brand
VERTEX® Reconstruction System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
NAV2080
Device description
TAP NAV2080 VERT TAP 4.5MM
Published
2016-07-01
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
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143628000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143628000Navigated Vertex Select InstrumentsMedtronic Sofamor Danek USA, Inc.2015-02-12OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169474888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169474888006431694748886431694748880643169474888

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
00199150076161Medtronic Reusable InstrumentsX02260412026-06-05
00199150076178Medtronic Reusable InstrumentsX02260422026-06-05
00199150080304Medtronic Reusable InstrumentsX08032922026-06-05
00199150077359Medtronic Reusable InstrumentsEX02260492026-06-01
00199150077366Medtronic Reusable InstrumentsEX02260512026-06-01
00763000857844T2 STRATOSPHERE™ Expandable Corpectomy System43612552026-06-01
00763000857943T2 STRATOSPHERE™ Expandable Corpectomy System43612202026-06-01
00763000857998T2 STRATOSPHERE™ Expandable Corpectomy System43613082026-06-01
00763000881252Clydesdale™ Spinal System49860402026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493422596RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422664RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422671RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422688RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422695RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422701RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422718RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422770RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422787RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422794RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422800RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422817RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422824RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422831RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422848RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422855RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422862RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422879RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422886RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05