FDA.reportPublic FDA data

SAXXONY™ Posterior Cervical Thoracic System

Primary DI
00889929059142
Brand
SAXXONY™ Posterior Cervical Thoracic System
Company
NEXXT SPINE, LLC
Model
C12-02-15
Device description
Navigation Instrument Caddy
Published
2024-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889929059142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889929059142008899290591428899290591420889929059142

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

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
04052536085552neon3Ulrich GmbH & Co. KGLXH2026-05-28
M7403030028Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030029Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030030Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030031Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030032Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030033Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030034Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030035Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030036Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030059Discectomy SetSPINEOLOGY INC.LXH2026-05-28
M7403030060Discectomy SetSPINEOLOGY INC.LXH2026-05-28
00810166522816Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522823Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522830Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522847Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522854Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522861Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522878Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00889929072424Matrixx SystemNEXXT SPINE, LLCLXH2026-05-27
07640187918809Straight reamer handleMPS Micro Precision Systems AGLXH2026-05-27
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07613327114881XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327121919XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327126273AVS Anchor-C Cervical Cage SystemStryker CorporationLXH2019-11-25
07613327142662XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327142679XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327177480OASYSStryker CorporationLXH2019-11-25