FDA.report

Matrixx System

Primary DI
00889929050477
Brand
Matrixx System
Company
NEXXT SPINE, LLC
Model
I91-10-01
Device description
Osteotome, Straight 6mm
Published
2022-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889929050477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929050477008899290504778899290504770889929050477

GMDN Terms

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
317-436-7801Support@nexxtspine.com

Regulatory Flags

DUNS number
003489810
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00840067210765TrellOss®-A SA446H08182026-02-20
00840067210772TrellOss®-A SA446H08202026-02-20
00840067210789TrellOss®-A SA446H14082026-02-20
00840067210796TrellOss®-A SA446H14102026-02-20
00840067210802TrellOss®-A SA446H14122026-02-20
00840067210819TrellOss®-A SA446H14142026-02-20
00840067210826TrellOss®-A SA446H14162026-02-20
00840067210833TrellOss®-A SA446H14182026-02-20
00840067210840TrellOss®-A SA446H14202026-02-20
00840067210857TrellOss®-A SA446H20122026-02-20
00840067210864TrellOss®-A SA446H20142026-02-20
00840067210871TrellOss®-A SA446H20162026-02-20
00840067210888TrellOss®-A SA446H20182026-02-20

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