FDA.reportPublic FDA data

DIVERGENCE® ANTERIOR CERVICAL FUSION SYSTEM

Primary DI
20763000873633
Brand
DIVERGENCE® ANTERIOR CERVICAL FUSION SYSTEM
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
G7743513
Device description
SCREW PK2 G7743513 MINIP S-T 3.5MM X13MM
Published
2025-04-10
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
20763000873633PrimaryGS10
00763000873639Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2076300087363320763000873633
00763000873639007630008736397630008736390763000873639

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
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00763000704483MSB CAPSTONE CONTROL™ Spinal System40016272026-07-20
00763000879556MSB Reusable Instruments5210-10222026-07-20
00763000992439MSB INFINITY OCT SystemG365PT40262026-07-20
00763000992446MSB INFINITY OCT SystemG365PT40282026-07-20
00763000993092MSB INFINITY OCT SystemG36555352026-07-20
00199150041183N/A593250152026-07-17
00199150072323Medtronic Reusable InstrumentsX66309032026-07-19
00199150074525Medtronic Reusable InstrumentsEX01260082026-07-19
00199150076024Medtronic Reusable InstrumentsEX03260062026-07-17
00199150081875Medtronic Reusable InstrumentsX04260032026-07-19
00643169511651SOVEREIGN™ Spinal System90100020222026-07-19
00643169511675MSB SOVEREIGN™ Spinal System90100020232026-07-19
00643169511682MSB SOVEREIGN™ Spinal System90100020242026-07-19
00643169511705MSB SOVEREIGN™ Spinal System90100020302026-07-17
00643169511712MSB SOVEREIGN™ Spinal System90100020312026-07-19
00643169511729MSB SOVEREIGN™ Spinal System90100020322026-07-19
00643169511736MSB SOVEREIGN™ Spinal System90100020332026-07-19
00643169511774MSB SOVEREIGN™ Spinal System90100020342026-07-19
00643169511781MSB SOVEREIGN™ Spinal System90100020352026-07-19
00643169511798MSB SOVEREIGN™ Spinal System90100020362026-07-19

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Primary DI, Brand, Company table
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