FDA.report

CD HORIZON® Spinal System

Primary DI
00613994238481
Brand
CD HORIZON® Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7895040
Device description
ROD 7895040 CURVED 5.5MM X 40MM PEEK
Published
2015-07-28
Public version status
Update
Distribution status
Not 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
NKBOrthosis, spinal pedicle fixation, for degenerative disc disease

Product Code Classifications

CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions

SubmissionSupplement
K063670000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K063670000MODIFICATIONS TO CD HORIZON SPINAL SYSTEMMedtronic Sofamor Danek2007-06-28NKB

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00613994238481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994238481006139942384816139942384810613994238481

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
Length40Millimeter
Outer Diameter5.5Millimeter

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

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