FDA.reportPublic FDA data

DOLOMITE

Primary DI
00840085239359
Brand
DOLOMITE
Company
Astura Medical
Model
LZFMBA12C
Catalog number
LZFMBA12C
Device description
ZERO PLATE TRIAL RASP
Published
2021-07-27
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
OVEIntervertebral Fusion Device With Integrated Fixation, Cervical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840085239359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085239359008400852393598400852393590840085239359

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle13degree
Height12Millimeter
Length14Millimeter
Width16Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7608148047PARKER@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
00843511102135Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102142Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102159Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102166Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102173Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102180Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102197Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102203Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102210Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102227Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102234Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102241Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102258Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102265Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102272Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102289Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102296Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102302Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102319Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102326Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102333Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102340Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102357Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102364Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102371Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102388Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102395Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102401Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102418Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22
00843511102425Omnia Medical TiBrid™-TCOMNIA MEDICAL, LLCODP2026-07-22