FDA.reportPublic FDA data

CD HORIZON® Spinal System

Primary DI
00763000516215
Brand
CD HORIZON® Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
RBT090015
Device description
TRAY RBT090015 MAZOR MIDLINE UPPER
Published
2021-11-19
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
K182121000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182121000CD HORIZON Spinal System Instruments for use with MAZOR X Stealth EditionMedtronic Sofamor Danek USA, Inc.2018-11-02OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000516215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000516215007630005162157630005162150763000516215

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862656117NewtonExactech, Inc.OLO2026-05-27
10885862656124NewtonExactech, Inc.OLO2026-05-27
10885862656131NewtonExactech, Inc.OLO2026-05-27
10885862656148NewtonExactech, Inc.OLO2026-05-27
10885862656155NewtonExactech, Inc.OLO2026-05-27
10885862656162NewtonExactech, Inc.OLO2026-05-27
10885862656179NewtonExactech, Inc.OLO2026-05-27
07613327594829Common Shoulder DriverMAKO SURGICAL CORP.OLO2026-05-21
07613327595543MakoMAKO SURGICAL CORP.OLO2026-05-21
07640221373021PERLA NAVSpineArt SAOLO2026-05-07
07640221373052PERLA NAVSpineArt SAOLO2026-05-07
07640221373069PERLA NAVSpineArt SAOLO2026-05-07
07640221373113PERLA NAVSpineArt SAOLO2026-05-07
07640221373120PERLA NAVSpineArt SAOLO2026-05-07
07640221373137PERLA NAVSpineArt SAOLO2026-05-07
07640221373144PERLA NAVSpineArt SAOLO2026-05-07
07640221373151PERLA NAVSpineArt SAOLO2026-05-07
07640221373168PERLA NAVSpineArt SAOLO2026-05-07
07640221373175PERLA NAVSpineArt SAOLO2026-05-07
07640221373182PERLA NAVSpineArt SAOLO2026-05-07
07640221373199PERLA NAVSpineArt SAOLO2026-05-07
07640221373205PERLA NAVSpineArt SAOLO2026-05-07
07640221373212PERLA NAVSpineArt SAOLO2026-05-07
07640221373229PERLA NAVSpineArt SAOLO2026-05-07
07640221373236PERLA NAVSpineArt SAOLO2026-05-07
07640221373243PERLA NAVSpineArt SAOLO2026-05-07
07640221373250PERLA NAVSpineArt SAOLO2026-05-07
07640221373267PERLA NAVSpineArt SAOLO2026-05-07
07640221373274PERLA NAVSpineArt SAOLO2026-05-07
07640221373281PERLA NAVSpineArt SAOLO2026-05-07