FDA.report

CD HORIZON® Spinal System

Primary DI
00613994123992
Brand
CD HORIZON® Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7573725
Device description
SCREW 7573725 CANN FA 7.5X25 TI
Published
2015-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications

CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00613994123992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994123992006139941239926139941239920613994123992

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes

TypeValueUnit
Length25Millimeter
Outer Diameter7.5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
830350380
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00763000887131CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887162CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887179CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
088000333582064CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2020-03-26
088000333846944CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
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088000333847624CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
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088000333850974CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-12-11
088000333851104CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-12-11
088000333859984CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
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088000333860494CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860564CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860634CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860704CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
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088000333861004CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861174CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861244CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861314CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861484CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
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