FDA.reportPublic FDA data

CD HORIZON® Spinal System

Primary DI
00763000351885
Brand
CD HORIZON® Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
RBT074110
Device description
CANNULA RBT074110 RG 10.5 CANNULA SHORT
Published
2021-12-11
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
MAXIntervertebral fusion device with bone graft, lumbar
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211596000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211596000CD Horizon Spinal SystemMedtronic2021-06-23OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000351885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000351885007630003518857630003518850763000351885

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
00643169964938GRAFTON™ DBMT42275INT2024-12-05
00643169965102GRAFTON PLUS™ DBMT45005INT2024-11-15
00763000140502PROGENIX™ PUTTY and PROGENIX™ PLUS0005052021-03-12
00763000140519PROGENIX™ PUTTY and PROGENIX™ PLUS0050012021-03-12
00763000140526PROGENIX™ PUTTY and PROGENIX™ PLUS0050052021-03-12
00763000140533PROGENIX™ PUTTY and PROGENIX™ PLUS0051102021-03-12
00763000140540PROGENIX™ PUTTY and PROGENIX™ PLUS0060012021-03-12
00763000140557PROGENIX™ PUTTY and PROGENIX™ PLUS0060022021-03-12
00763000140564PROGENIX™ PUTTY and PROGENIX™ PLUS0060052021-03-12
00763000140571PROGENIX™ PUTTY and PROGENIX™ PLUS0060102021-03-12
00643169965089GRAFTON® DBMT44150INT2019-02-07
00613994247612PROGENIX® PUTTY and PROGENIX® PLUS0051102019-03-29
00885074012292MASTERGRAFT® MATRIX76003102015-07-20
00885074012308MASTERGRAFT® MATRIX76003202015-07-20
00885074327266MASTERGRAFT® MATRIX76003052015-07-20
00885074478715MASTERGRAFT®Putty76007012015-07-20
00885074478753MASTERGRAFT®Putty76007022015-07-20
00885074478760MASTERGRAFT®Putty76007032015-07-20
00885074478784MASTERGRAFT®Putty76007062015-07-20
00885074478791MASTERGRAFT®Putty76007092015-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556924327Real IntelligenceSmith & Nephew, Inc.OLO2026-10-08
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00810017916252SABER-XA, Expandable Spacer, 40x30mm, 13mm, (12°)ELEVATION SPINE, INC.MAX2026-10-07
00810017916269SABER-XA, Expandable Spacer, 40x30mm, 16mm, (18°)ELEVATION SPINE, INC.MAX2026-10-07
00810017916184SABER-XA, Expandable Spacer, 37x28mm,13mm, (12°)ELEVATION SPINE, INC.MAX2026-10-01
10888857160460CASCADIA™ Interbody SystemVB Spine LLCMAX2018-04-16
07640139342287Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139342294Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139342300Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139342317Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
07640139343819Dynamik Intervertebral Body Fusion DeviceSpineArt SAMAX2018-03-12
10888857223769CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223776CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223783CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223790CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223868CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223875CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223882CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223899CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223967CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223974CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223981CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
10888857223998CASCADIA™ Interbody SystemVB Spine LLCMAX2018-02-08
04546540717443ORTHOMAPStryker Leibinger GmbH & Co. KGOLO2017-12-12
10888857217355CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217362CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217379CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217386CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217393CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19
10888857217454CASCADIA™ Interbody SystemVB Spine LLCMAX2017-07-19