FDA.reportPublic FDA data

EL CAPITAN

Primary DI
00840085217845
Brand
EL CAPITAN
Company
Astura Medical
Model
KF0000020
Catalog number
KF0000020
Device description
ALIF NAIL
Published
2021-08-03
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
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840085217845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840085217845008400852178458400852178450840085217845

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
Length20Millimeter
Width5.5Millimeter

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
07613153046196AVS PLStryker CorporationOVD2015-09-14
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07613153046318AVS PLStryker CorporationOVD2015-09-14
07613153046349AVS PLStryker CorporationOVD2015-09-14
07613153046356AVS PLStryker CorporationOVD2015-09-14
07613153046363AVS PLStryker CorporationOVD2015-09-14
07613153046370AVS PLStryker CorporationOVD2015-09-14
07613153046400AVS TLStryker CorporationOVD2015-09-14
07613153046417AVS TLStryker CorporationOVD2015-09-14
07613153046431AVS TLStryker CorporationOVD2015-09-14
07613153046448AVS TLStryker CorporationOVD2015-09-14
07613153046455AVS TLStryker CorporationOVD2015-09-14
07613153046516AVS TLStryker CorporationOVD2015-09-14
07613153046523AVS TLStryker CorporationOVD2015-09-14
07613153046554AVS TLStryker CorporationOVD2015-09-14
07613153046561AVS TLStryker CorporationOVD2015-09-14
07613153046578AVS TLStryker CorporationOVD2015-09-14
07613153046585AVS TLStryker CorporationOVD2015-09-14
07613153046592AVS TLStryker CorporationOVD2015-09-14
07613153046608AVS TLStryker CorporationOVD2015-09-14
07613153046615AVS TLStryker CorporationOVD2015-09-14
07613153046622AVS TLStryker CorporationOVD2015-09-14
07613153046639AVS TLStryker CorporationOVD2015-09-14
07613153046646AVS TLStryker CorporationOVD2015-09-14
07613153046653AVS TLStryker CorporationOVD2015-09-14
07613153046660AVS TLStryker CorporationOVD2015-09-14
07613153046677AVS TLStryker CorporationOVD2015-09-14
07613153046691AVS TLStryker CorporationOVD2015-09-14