FDA.reportPublic FDA data

Solera

Primary DI
00643169541023
Brand
Solera
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
NAV2013K
Device description
TAP NAV2013K SOLERA AWLTIPTAP 10MM
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
00643169541023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169541023006431695410236431695410230643169541023

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter10Millimeter

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
20763000866253CD Horizon™ ModuLeX™ FNS Screw Set559025255352024-12-29
00763000884550n/a70809182025-06-30
00763000750282CD HORIZON® Fenestrated Screw Spinal System557510255452026-11-01
00763000750411CD HORIZON® Fenestrated Screw Spinal System557510265552026-11-01
00763000750497MSB CD HORIZON® Fenestrated Screw Spinal System557510275402026-10-31
00763000750503CD HORIZON® Fenestrated Screw Spinal System557510275452026-11-01
00763000774165CD HORIZON Spinal System557500165302026-10-31
00763000774172MSB CD HORIZON Spinal System557500165352026-10-31
00763000774189MSB CD HORIZON Spinal System557500165402026-10-31
00763000774196MSB CD HORIZON Spinal System557500165452026-10-31
00763000774202MSB CD HORIZON Spinal System557500165502026-10-31
00763000774226MSB CD HORIZON Spinal System557500175352026-10-31
00763000774240MSB CD HORIZON Spinal System557500175452026-10-31
00763000774257MSB CD HORIZON Spinal System557500175502026-10-31
00763000774301MSB CD HORIZON Spinal System557500185452026-10-31
00763000777418CD HORIZON Spinal System557500455352026-11-01
00763000777517CD HORIZON Spinal System557500465402026-11-01
00763000777524CD HORIZON Spinal System557500465452026-11-01
00763000777692MSB CD HORIZON Spinal System557500155302026-10-31
00763000777739MSB CD HORIZON Spinal System557500155502026-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810141048072Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048089Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048096Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048102Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048126Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048133Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048140Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048157Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048171Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048225Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048232Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048249Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048256Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048263Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048270Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048287Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048294Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048300Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048317Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048324Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
00810141048331Foundation Surgical Navigated Lateral Disc PrepFOUNDATION SURGICAL GROUP INCOLO2026-11-05
M946109900N1TMINI® Guide Block Kit compatible with DePuy Synthes® ATTUNE® Knee System (10ea)THINK SURGICAL, INC.OLO2026-11-05
M9461100501TMINI® Guide Block Kit compatible with DePuy Synthes® ATTUNE® Knee SystemTHINK SURGICAL, INC.OLO2026-11-05
00763000777418CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-11-01
00763000777517CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-11-01
00763000777524CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-11-01
00763000774165CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774172MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774189MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31
00763000774196MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-31