FDA.reportPublic FDA data

DOMINION

Primary DI
00840085271014
Brand
DOMINION
Company
Astura Medical
Model
TA1204160
Catalog number
TA1204160
Device description
EXPANDABLE COLUMN
Published
2024-10-22
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
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840085271014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085271014008400852710148400852710140840085271014

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height60Millimeter
Outer Diameter12Millimeter

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
B678522207S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522208S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522209S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522210S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522211S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522212S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522213S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522214S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522215S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522216S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-30
B678522201S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522202S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522203S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522204S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522205S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
B678522206S0Tranquil-C™NEXUS SPINE, L.L.C.ODP2026-10-29
00810017913763Saber-C Body (PT), 14x15x5 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913770Saber-C Body (PT), 14x15x6 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913787Saber-C Body (PT), 14x15x7 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913794Saber-C Body (PT), 14x15x8 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913800Saber-C Body (PT), 14x15x9 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913817Saber-C Body (PT), 14x15x10 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913824Saber-C Body (PT), 14x15x5 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913930Saber-C Body (PT), 14x17x10 6 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913947Saber-C Body (PT), 14x17x5 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913954Saber-C Body (PT), 14x17x6 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913961Saber-C Body (PT), 14x17x7 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913978Saber-C Body (PT), 14x17x8 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913985Saber-C Body (PT), 14x17x9 9 deg.ELEVATION SPINE, INC.ODP2026-10-26
00810017913992Saber-C Body (PT), 14x17x10 9 deg.ELEVATION SPINE, INC.ODP2026-10-26