FDA.reportPublic FDA data

n/a

Primary DI
00613994980007
Brand
n/a
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7069033
Device description
LID 7069033 5.5 SET SCREW MODULE
Published
2021-10-18
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
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAppliance, fixation, spinal intervertebral body
MNHOrthosis, spondylolisthesis spinal fixation
MNIOrthosis, spinal pedicle fixation
NKBThoracolumbosacral pedicle screw system
OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153442000CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE SystemsMedtronic Sofamor Danek USA, Inc.2016-02-18NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994980007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994980007006139949800076139949800070613994980007

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing clinical instruments (typically endoscopes or surgical instruments) for use during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It is typically in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

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
00643169524699Reusable Instruments21511302026-09-20
00763000891428CD HORIZON Spinal System559006001602026-09-20
00763000891480CD HORIZON Spinal System559006185502026-09-20
00763000992538INFINITY OCT SystemG36535122026-09-20
00763000992545INFINITY OCT SystemG36535142026-09-20
00763000992569INFINITY OCT SystemG36535182026-09-20
00824846008477Medtronic Reusable InstrumentsEX29420202026-09-19
00763000703929MSB CAPSTONE CONTROL™ Spinal System39914222026-08-27
00763000703936MSB CAPSTONE CONTROL™ Spinal System39914272026-08-27
00763000703950MSB CAPSTONE CONTROL™ Spinal System39915222026-08-27
00763000703967MSB CAPSTONE CONTROL™ Spinal System39915272026-08-27
00763000703981MSB CAPSTONE CONTROL™ Spinal System39916222026-08-27
00763000703998MSB CAPSTONE CONTROL™ Spinal System39916272026-08-27
00763000704001MSB CAPSTONE CONTROL™ Spinal System39916322026-08-27
00763000704018MSB CAPSTONE CONTROL™ Spinal System39917222026-08-27
00763000704025MSB CAPSTONE CONTROL™ Spinal System39917272026-08-27
00763000704032MSB CAPSTONE CONTROL™ Spinal System39917322026-08-27
00763000704049MSB CAPSTONE CONTROL™ Spinal System39913322026-08-27
00763000704063MSB CAPSTONE CONTROL™ Spinal System39908272026-08-27
00763000704070MSB CAPSTONE CONTROL™ Spinal System39909222026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000891428CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-09-20
00763000891428CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-09-20
00763000891428CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-09-20
00763000891480CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-09-20
00763000891480CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-09-20
00763000891480CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-09-20
00197157116712ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116729ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116736ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116743ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116750ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116767ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116774ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116781ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116798ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116804ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116811ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116828ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116835ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116842ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116859ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116866ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116873ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116880ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116897ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116903ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116910ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116927ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116934ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116941ZAVATION SCREWZavation LLCNKB2026-09-18