FDA.reportPublic FDA data

Inertia® MIS Pedicle Screw System

Primary DI
00889929019092
Brand
Inertia® MIS Pedicle Screw System
Company
NEXXT SPINE, LLC
Model
I10-14-75AWL
Device description
Awl Tap, SQR, 7.5mm
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWJAwl
HWXTap, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1
HWXTap, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889929019092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929019092008899290190928899290190920889929019092

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889929072424Matrixx SystemI92-20-022026-05-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09120125220280Shark Screw® tapsurgebright GmbHHWX2026-04-30
10705034577913N/AMedos International SàrlHWX2026-04-23
10705034577920N/AMedos International SàrlHWX2026-04-23
10705034577937N/AMedos International SàrlHWX2026-04-23
10705034577944N/AMedos International SàrlHWX2026-04-23
10705034577951N/AMedos International SàrlHWX2026-04-23
10705034577968N/AMedos International SàrlHWX2026-04-23
10705034577975N/AMedos International SàrlHWX2026-04-23
10705034577982N/AMedos International SàrlHWX2026-04-23
10705034577999N/AMedos International SàrlHWX2026-04-23
G079C5020000950Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001000Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001050Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
07640375234773SCARLET AL-T INSTRUMENTATIONSpineArt SAHWJ2025-11-10
07640450868374PERLA ®SpineArt SAHWX2025-11-10
07640450868381PERLA ®SpineArt SAHWX2025-11-10
08059386744338Orthopaedic Surgical InstrumentsCITIEFFE SRLHWJ2025-11-06
08800308480564INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480571INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480588INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480595INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
08800308480601INNOVERSE Spinal SystemCG MedTech Co.,Ltd.HWX2025-10-23
09120129291507Awl, Curved, CannulatedI.T.S. GmbHHWJ2025-10-21
09120129291514Awl TrocarI.T.S. GmbHHWJ2025-10-21
09120125220136Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220143Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220150Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220167Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220174Shark Screw® tapsurgebright GmbHHWX2025-09-16
09120125220181Shark Screw® tapsurgebright GmbHHWX2025-09-16