FDA.reportPublic FDA data

Inertia® CONNEXX™ Modular Pedicle Screw System

Primary DI
00889929063620
Brand
Inertia® CONNEXX™ Modular Pedicle Screw System
Company
NEXXT SPINE, LLC
Model
20-28R-25
Device description
Bypass Rod, Right, 25mm
Published
2024-12-20
Public version status
New
Distribution status
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
NKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231799000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231799000INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC2023-07-20NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889929063620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929063620008899290636208899290636200889929063620

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system connectorAn implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, 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)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter25Millimeter

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
00889929072523Struxxure® Plate System63-55T-152026-05-14
00889929072530Struxxure® Plate System63-55T-202026-05-14
00889929072547Struxxure® Plate System63-55T-252026-05-14
00889929072554Struxxure® Plate System63-55T-302026-05-14
00889929072561Struxxure® Plate System63-55T-352026-05-14
00889929072578Struxxure® Plate System63-55T-402026-05-14
00889929072585Struxxure® Plate System63-55T-452026-05-14
00889929072592Struxxure® Plate System63-55T-502026-05-14
00889929072608Struxxure® Plate System63-55T-552026-05-14
00889929072615Struxxure® Plate System63-55T-602026-05-14
00889929072622Struxxure® Plate System63-60T-152026-05-14
00889929072639Struxxure® Plate System63-60T-202026-05-14
00889929072646Struxxure® Plate System63-60T-252026-05-14
00889929072653Struxxure® Plate System63-60T-302026-05-14
00889929072660Struxxure® Plate System63-60T-352026-05-14
00889929072677Struxxure® Plate System63-60T-402026-05-14
00889929072684Struxxure® Plate System63-60T-452026-05-14
00889929072691Struxxure® Plate System63-60T-502026-05-14
00889929072707Struxxure® Plate System63-60T-552026-05-14
00889929072714Struxxure® Plate System63-60T-602026-05-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613153045762XIA IIStryker CorporationNKB2014-12-08
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07613153045861XIA IIStryker CorporationNKB2014-12-08
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07613153045908XIA IIStryker CorporationNKB2014-12-08
07613153045915XIA IIStryker CorporationNKB2014-12-08
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07613153046172XIA STAINLESS STEELStryker CorporationNKB2014-12-08
07613153140344XIA IIStryker CorporationNKB2014-12-08
07613153140351XIA IIStryker CorporationNKB2014-12-08
07613153140368XIA IIStryker CorporationNKB2014-12-08
07613153140382XIA IIStryker CorporationNKB2014-12-08
07613153143512XIA STAINLESS STEELStryker CorporationNKB2014-12-08