FDA.reportPublic FDA data

Inertia® Pedicle Screw System

Primary DI
00889929022993
Brand
Inertia® Pedicle Screw System
Company
NEXXT SPINE, LLC
Model
10-17-55145
Device description
MIS Rod, Curved, Ø5.5mm x 145mm
Published
2017-10-13
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
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090984000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090984000INERTIA PEDICLE SCREW SYSTEMNexxt Spine, LLC2009-06-30MNI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889929022993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929022993008899290229938899290229930889929022993

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system rodAn implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length145Millimeter
Outer Diameter5.5Millimeter

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
00889929072929HONOUR® Spacer SystemI21-01-042026-07-29
00889929072936HONOUR® Spacer SystemI21-01-052026-07-29
00889929072820Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95602026-07-20
00889929072837Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95652026-07-20
00889929072844Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95702026-07-20
00889929072851Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95752026-07-20
00889929072868Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95802026-07-20
00889929072875Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95852026-07-20
00889929072882Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95902026-07-20
00889929072899Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-95952026-07-20
00889929072905Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-951052026-07-20
00889929072912Inertia® CONNEXX™ Modular Pedicle Screw System20-SCS-951152026-07-20
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M719IST80030C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
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M719IST80035C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80040C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80040C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80045C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80045C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80050C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80050C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80055C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
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M719IST80060C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80060C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80065C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80065C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80070C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80070C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80075C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80075C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80080C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80080C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80085C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80085C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80090C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80090C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80095C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80095C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18
M719IST80100C0TiLockGenesys Orthopedics Systems LLCMNI2026-08-18
M719IST80100C0TiLockGenesys Orthopedics Systems LLCMNH2026-08-18