FDA.reportPublic FDA data

Blade® Anterior Cervical Plate System

Primary DI
00889929000458
Brand
Blade® Anterior Cervical Plate System
Company
NEXXT SPINE, LLC
Model
30-4-76
Device description
Cervical Plate, 4 Level 76mm
Published
2015-07-30
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091936000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091936000BLADE ANTERIOR CERVICAL PLATE SYSTEMNexxt Medical, Inc.2010-01-19KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889929000458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929000458008899290004588899290004580889929000458

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; 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 typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length76Millimeter

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
00889929072943Inertia® Pedicle Screw SystemI10-05-06M2026-08-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10888857037977EVEREST® Spinal SystemVB Spine LLCKWQ2026-06-11
10888857001428DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001435DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001459DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001657DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001688DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001695DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001701DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857001718DENALI® MI Spinal SystemVB Spine LLCKWQ2018-11-05
10888857046733MESA® Small Stature Spinal SystemVB Spine LLCKWQ2016-09-02
10888857008724EVEREST® Spinal SystemVB Spine LLCKWQ2016-03-10
10888857001497DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001527DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001589DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001619DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001640DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001725DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001763DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001787DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001824DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001848DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001923DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001947DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001978DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857001992DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002036DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002050DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002074DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24
10888857002098DENALI® MI Spinal SystemVB Spine LLCKWQ2015-09-24