FDA.reportPublic FDA data

OLYMPIC

Primary DI
00841379185376
Brand
OLYMPIC
Company
Astura Medical
Model
AGGA50030
Catalog number
AGGA50030
Device description
HIGH TOP UNIPLANAR SCREW
Published
2021-08-02
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
KWPAppliance, Fixation, Spinal Interlaminal
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841379185376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841379185376008413791853768413791853760841379185376

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it 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 available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Millimeter
Width5Millimeter

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
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07613153143741XIA STAINLESS STEELStryker CorporationKWP2015-09-14
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07613154129867OASYSStryker CorporationKWP2015-09-14
07613154170142OASYSStryker CorporationKWP2015-09-14
07613153045670XIA IStryker CorporationKWP2014-12-08
07613153045670XIA IStryker CorporationNKB2014-12-08
07613153045700XIA IStryker CorporationKWP2014-12-08
07613153045717XIA IStryker CorporationNKB2014-12-08
07613153045717XIA IStryker CorporationKWP2014-12-08
07613153045724XIA IStryker CorporationKWP2014-12-08
07613153045724XIA IStryker CorporationNKB2014-12-08
07613153045731XIA IStryker CorporationKWP2014-12-08
07613153045748XIA IStryker CorporationNKB2014-12-08
07613153045755XIA IStryker CorporationNKB2014-12-08
07613153045755XIA IStryker CorporationKWP2014-12-08
07613153045762XIA IIStryker CorporationKWP2014-12-08
07613153045762XIA IIStryker CorporationNKB2014-12-08
07613153045793XIA IIStryker CorporationKWP2014-12-08
07613153045847XIA IIStryker CorporationNKB2014-12-08
07613153045847XIA IIStryker CorporationKWP2014-12-08
07613153045854XIA IIStryker CorporationKWP2014-12-08
07613153045854XIA IIStryker CorporationNKB2014-12-08
07613153045861XIA IIStryker CorporationNKB2014-12-08
07613153045861XIA IIStryker CorporationKWP2014-12-08
07613153045878XIA IIStryker CorporationKWP2014-12-08
07613153045885XIA IIStryker CorporationKWP2014-12-08
07613153045885XIA IIStryker CorporationNKB2014-12-08
07613153045892XIA IIStryker CorporationNKB2014-12-08
07613153045892XIA IIStryker CorporationKWP2014-12-08