FDA.reportPublic FDA data

Solera

Primary DI
00643169545809
Brand
Solera
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
NAV2019K
Device description
DRIVER NAV2019K SOLERA 5.5/6 MAS LG
Published
2016-08-29
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
K140454000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140454000NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPSMedtronic Sofamor Danek USA, Inc.2014-05-22OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169545809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169545809006431695458096431695458090643169545809

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width5.5Millimeter
Width6Millimeter

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