FDA.reportPublic FDA data

DOMINION

Primary DI
00840085272998
Brand
DOMINION
Company
Astura Medical
Model
TA1606297
Catalog number
TA1606297
Device description
EXPANDABLE COLUMN, 16MM,
Published
2024-10-23
Public version status
Update
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
LXHOrthopedic Manual Surgical Instrument
MQPSpinal Vertebral Body Replacement Device
PLRSpinal Vertebral Body Replacement Device - Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2
PLRSpinal Vertebral Body Replacement Device - CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840085272998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085272998008400852729988400852729980840085272998

GMDN Terms#

Term, Definition table
TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height97Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7608148047TROY@ASTURAMEDICAL.COM

Regulatory Flags#

DUNS number
073029645
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840085244919OLYMPICAZC010030AZC0100302026-04-15
00840085252761OLYMPICAZC170000AZC1700002026-04-15
00840085213120SIRIONGZC11D10AGZC11D10A2021-07-15
00841379186588SIRIONGZB13AE02GZB13AE022021-07-13
00840085201585SIRIONGZA150000GZA1500002021-07-12
00840085278518ALTANBT095060NBT0950602026-02-03
00840085277603ALTANBF045025NBF0450252026-02-02
00840085278051ALTANBF095060NBF0950602026-02-02
00840085278068ALTANBT045025NBT0450252026-02-02
00840085219641EL CAPITANKZB100000KZB1000002021-07-30
00840085233500DOLOMITELZA040000LZA0400002021-07-27
00840085233517DOLOMITELZA050000LZA0500002021-07-27
00840085233524DOLOMITELZA060000LZA0600002021-07-27
00840085235078DOLOMITELZB040000LZB0400002021-07-27
00840085235085DOLOMITELZB050000LZB0500002021-07-27
00840085236938DOLOMITELZD020000LZD0200002021-07-27
00840085236990DOLOMITELZD060000LZD0600002021-07-27
00840085242274DOLOMITELZD070000LZD0700002021-07-27
00840085272271ASYNJABB00025JABB000252024-01-09
00840085272288ASYNJABB00050JABB000502024-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327007114ES2 SPINAL SYSTEMStryker CorporationLXH2019-11-25
07613327007558XIA 3Stryker CorporationLXH2019-11-25
07613327007565XIA 3Stryker CorporationLXH2019-11-25
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
07613327114799XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-21
07613327114850XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-21
07613327006223ARIAStryker CorporationLXH2019-11-20
07613327006919ES2 SPINAL SYSTEMStryker CorporationLXH2019-11-20
07613327006926ES2 SPINAL SYSTEMStryker CorporationLXH2019-11-20
07613327006940ES2 SPINAL SYSTEMStryker CorporationLXH2019-11-20
07613327006957ES2 SPINAL SYSTEMStryker CorporationLXH2019-11-20
07613327114812XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-20
07613327114843XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-20
07613327114874ES2 SPINAL SYSTEMStryker CorporationLXH2019-11-20
07613327119022LITe DECOMPRESSIONStryker CorporationLXH2019-11-20
07613327119046LITe DECOMPRESSIONStryker CorporationLXH2019-11-20
07613327121933XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-20
07613327121940XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-20
07613327135268UniVise Spinous Process Fixation Plate SystemStryker CorporationLXH2019-11-20
07613327142075XIA 3Stryker CorporationLXH2019-11-20
07613153088424NASTRYKER CORPORATIONLXH2018-09-24
07613154639496NAStryker GmbHLXH2018-09-24
07613154639502NAStryker GmbHLXH2018-09-24
07613154639519NAStryker GmbHLXH2018-09-24
07613154639526NAStryker GmbHLXH2018-09-24
07613154639533NAStryker GmbHLXH2018-09-24
07613154639540NAStryker GmbHLXH2018-09-24