DIVERGENCE® ANTERIOR CERVICAL FUSION SYSTEM

Primary DI
20763000873640
Brand
DIVERGENCE® ANTERIOR CERVICAL FUSION SYSTEM
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
G7743511
Device description
SCREW PK2 G7743511 MINIP S-T 3.5MM X11MM
Published
2025-04-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140417000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140417000DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEMMedtronic Sofamor Danek, Inc.2014-07-09KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20763000873640PrimaryGS10
00763000873646Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300087364020763000873640
00763000873646007630008736467630008736460763000873646

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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
2
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150002139N/A593250132026-07-16
00199150002146N/A593250162026-07-16
00199150015832INFINITY™ Occipitocervical Upper Thoracic System365370252026-07-16
00199150015849INFINITY™ Occipitocervical Upper Thoracic System365370302026-07-16
00199150015856INFINITY™ Occipitocervical Upper Thoracic System365370352026-07-16
00199150015863INFINITY™ Occipitocervical Upper Thoracic System365370402026-07-16
00199150015870INFINITY™ Occipitocervical Upper Thoracic System365370452026-07-16
00199150015887INFINITY™ Occipitocervical Upper Thoracic System365370502026-07-16
00199150015894INFINITY™ Occipitocervical Upper Thoracic System365370552026-07-16
00199150015900INFINITY™ Occipitocervical Upper Thoracic System365370602026-07-16
00199150015917INFINITY™ Occipitocervical Upper Thoracic System365370652026-07-16
00199150015924INFINITY™ Occipitocervical Upper Thoracic System365370702026-07-16
00199150015931INFINITY™ Occipitocervical Upper Thoracic System365370752026-07-16
00199150015948INFINITY™ Occipitocervical Upper Thoracic System365370802026-07-16
00199150015955INFINITY™ Occipitocervical Upper Thoracic System365370852026-07-16
00199150015962INFINITY™ Occipitocervical Upper Thoracic System365370902026-07-16
00199150015986INFINITY™ Occipitocervical Upper Thoracic System365371002026-07-16
00199150016006INFINITY™ Occipitocervical Upper Thoracic System365371102026-07-16
00199150016013INFINITY™ Occipitocervical Upper Thoracic System365371202026-07-16
00199150016037INFINITY™ Occipitocervical Upper Thoracic System365350602026-07-16

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