INGENIX

Primary DI
00843672101725
Brand
INGENIX
Company
INGENIUMSPINE, LLC
Model
55056530
Device description
Polyax Deformity Screw Kit 6.5x30mm for 5.5mm Rod
Published
2025-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNBInstrument, Destructive, Fetal, Obstetric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNBInstrument, Destructive, Fetal, ObstetricObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241258000Ingenix Spinal SystemIngenium Spine2024-06-04NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00843672101725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843672101725008436721017258436721017250843672101725

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

Regulatory Flags#

DUNS number
082805471
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843672101596Ingenix550275602022-05-14
00843672101602Ingenix550265652022-05-14
00843672101619Ingenix550275702022-05-14
00843672101626Ingenix550275752022-05-14
00843672101633Ingenix550275802022-05-14
00843672101640Ingenix550175702022-05-14
00843672101657Ingenix550175802022-05-14
00843672100216INGENIX550165452018-06-15
00843672100070INGENIX550155352018-06-15
00843672100001INGENIX550147302018-06-15
00843672100018INGENIX550147352018-06-15
00843672100025INGENIX550147402018-06-15
00843672100032INGENIX550147452018-06-15
00843672100049INGENIX550147502018-06-15
00843672100056INGENIX550147552018-06-15
00843672100087INGENIX550155402018-06-15
00843672100094INGENIX550155452018-06-15
00843672100100INGENIX550155502018-06-15
00843672100117INGENIX550155552018-06-15
00843672100124INGENIX550160302018-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843672101831INGENIXINGENIUMSPINE, LLCKNB2025-02-24
00840314118998Nex-D2NEXT ORTHOSURGICAL, INC.KNB2024-08-28
G079C25200A0650MIS Golden Isles Pedicle Screw System Intelivation, LLCKNB2023-04-27
G079C25200A0700MIS Golden Isles Pedicle Screw System Intelivation, LLCKNB2023-04-27
00815500024636DymaxeonBACK 2 BASIC DIRECT, LLCKNB2019-02-01
08806162106879AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KNB2015-10-13
08806162107418AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.KNB2015-10-13