FDA.reportPublic FDA data

Inertia® MIS Pedicle Screw System

Primary DI
00889929021620
Brand
Inertia® MIS Pedicle Screw System
Company
NEXXT SPINE, LLC
Model
10-64-7525
Device description
MIS, Pedicle Screw, Ø7.5x25 mm
Published
2017-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132412000INERTIA MIS PEDICLE SCREW SYSTEMNexxt Spine, LLC2013-10-10MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889929021620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929021620008899290216208899290216200889929021620

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used 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 (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length25Millimeter
Outer Diameter7.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
317-436-7801Support@nexxtspine.com

Regulatory Flags#

DUNS number
003489810
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889929072219NEXXT MATRIXX® SI SystemI64-05-072026-07-17
00889929072226NEXXT MATRIXX® SI SystemI64-05-082026-07-17
00889929072233NEXXT MATRIXX® SI SystemI64-05-092026-07-17
00889929072264NEXXT MATRIXX® SI SystemI64-05-312026-07-17
00889929072271NEXXT MATRIXX® SI SystemI64-08-112026-07-17
00889929072288NEXXT MATRIXX® SI SystemI64-20-042026-07-17
00889929072295NEXXT MATRIXX® SI SystemI64-25-012026-07-17
00889929072301NEXXT MATRIXX® SI SystemI64-25-022026-07-17
00889929072318NEXXT MATRIXX® SI SystemI64-25-032026-07-17
00889929072325NEXXT MATRIXX® SI SystemI64-25-042026-07-17
00889929072332NEXXT MATRIXX® SI SystemI64-25-052026-07-17
00889929072349Matrixx SystemI92-20-042026-07-17
00889929072356NEXXT MATRIXX® SI SystemI64-05-322026-07-17
00889929072363NEXXT MATRIXX® SI SystemI64-05-332026-07-17
00889929072394NEXXT MATRIXX® SI SystemI64-05-342026-07-17
00889929072448Matrixx SystemI91-20-022026-07-17
00889929072745NEXXT MATRIXX® SI SystemI64-15-072026-07-17
00889929060209Inertia® CONNEXX™ Modular Pedicle Screw System20-SCC-85852024-12-18
00889929072400NEXXT MATRIXX® SI SystemC64-01-032026-07-10
00889929072738NEXXT MATRIXX® SI SystemI64-15-082026-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000910365CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-18
20763000910376CD Horizon™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-18
00199150015832INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-16
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