FDA.reportPublic FDA data

CD HORIZON® Fenestrated Screw Set

Primary DI
00763000149574
Brand
CD HORIZON® Fenestrated Screw Set
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
55750025540
Device description
FNS MAS 55750025540 STER CCM 5.5 X 40
Published
2020-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDNCEMENT, BONE, VERTEBROPLASTY
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDNCement, Bone, VertebroplastyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201362000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201362000CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone CementMedtronic2020-08-19PML

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00763000149574PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00763000149574007630001495747630001495740763000149574

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of 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. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169839397INFINITY™ Occipitocervical Upper Thoracic System36070052018-06-10
00199150082780Medtronic Reusable InstrumentsX02260232026-07-04
00199150082797Medtronic Reusable InstrumentsX02260242026-07-04
00199150082803Medtronic Reusable InstrumentsX02260252026-07-04
00199150082810Medtronic Reusable InstrumentsX02260262026-07-04
00199150082827Medtronic Reusable InstrumentsX02260272026-07-04
00199150082834Medtronic Reusable InstrumentsX02260282026-07-04
00199150082841Medtronic Reusable InstrumentsX02260292026-07-04
00199150082858Medtronic Reusable InstrumentsX02260302026-07-04
00199150082865Medtronic Reusable InstrumentsX02260312026-07-04
00199150082872Medtronic Reusable InstrumentsX02260322026-07-04
00199150082889Medtronic Reusable InstrumentsX02260332026-07-04
00199150082896Medtronic Reusable InstrumentsX02260342026-07-04
00763000873714MSB SHILLA Growth Guidance System76750252026-07-04
00763000875176MSB SHILLA Growth Guidance System76755352026-07-04
00643169101296MSB VERTEX® Reconstruction SystemG77538052026-06-27
00643169465879MSB CD HORIZON Spinal SystemX10131802026-06-28
00763000857820T2 STRATOSPHERE™ Expandable Corpectomy System43612052026-06-26
00763000858001T2 STRATOSPHERE™ Expandable Corpectomy System4361203002026-06-26
00643169190542CLYDESDALE PTC™ Spinal System49868402016-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-06-28
10889981441555VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981065348MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065539MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065553MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065577MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065584MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065607MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065645MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065669MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065683MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065706MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065720MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065744MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065768MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065782MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065805MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065829MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065843MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065867MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065881MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065904MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065928MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065959MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065966MarinerSeaspine Orthopedics CorporationNKB2016-09-02
10889981065973MarinerSeaspine Orthopedics CorporationNKB2016-09-02