FDA.reportPublic FDA data

CD HORIZON® Spinal System

Primary DI
00763000274467
Brand
CD HORIZON® Spinal System
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
559200002
Device description
UAS/SETSCRW 559200002 5.5/6.0 STER 2PK
Published
2020-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201407000CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2020-09-10NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000274461PrimaryGS10
00763000274467Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300027446120763000274461
00763000274467007630002744677630002744670763000274467

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
2
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
false

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
00197157075835ZAVATION DRIVERZavation LLCNKB2026-05-27
00197157075842ZAVATION K-WIREZavation LLCNKB2026-05-27
06009699901715Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
06009699901722Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
00810088650970Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651052Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651144Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651151Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651168Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651175Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651182Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651366Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651373Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651380Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651397Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651403Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651588Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651595Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651601Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651618Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651625Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651632Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651809Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651816Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651823Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651830Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651847Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651854Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652035Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652042Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12