FDA.reportPublic FDA data

EUROPA™ Pedicle Screw

Primary DI
00810025482725
Brand
EUROPA™ Pedicle Screw
Company
MIRUS LLC
Model
1-2-9580
Device description
Ø9.5 X 80mm EUROPA™ Pedicle Screw
Published
2023-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MNHOrthosis, Spondylolisthesis Spinal Fixation
MNIOrthosis, Spinal Pedicle Fixation
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180337000
K182970000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180337000EUROPA Pedicle Screw SystemMiRus, LLC2019-03-14NKB
K182970000EUROPA™ Pedicle Screw SystemMiRus, LLC2019-01-22NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810025482725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810025482725008100254827258100254827250810025482725

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
080311078
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810116510009ANTARES Standalone ALIF System010-L-11082025-12-04
00810116510016ANTARES Standalone ALIF System010-L-12082025-12-04
00810116510023ANTARES Standalone ALIF System010-L-12122025-12-04
00810116510030ANTARES Standalone ALIF System010-L-13082025-12-04
00810116510047ANTARES Standalone ALIF System010-L-13122025-12-04
00810116510054ANTARES Standalone ALIF System010-L-13162025-12-04
00810116510061ANTARES Standalone ALIF System010-L-14082025-12-04
00810116510078ANTARES Standalone ALIF System010-L-14122025-12-04
00810116510085ANTARES Standalone ALIF System010-L-14162025-12-04
00810116510092ANTARES Standalone ALIF System010-L-14202025-12-04
00810116510108ANTARES Standalone ALIF System010-L-16082025-12-04
00810116510115ANTARES Standalone ALIF System010-L-16122025-12-04
00810116510122ANTARES Standalone ALIF System010-L-16162025-12-04
00810116510139ANTARES Standalone ALIF System010-L-16202025-12-04
00810116510146ANTARES Standalone ALIF System010-L-16252025-12-04
00810116510153ANTARES Standalone ALIF System010-L-18082025-12-04
00810116510160ANTARES Standalone ALIF System010-L-18122025-12-04
00810025487706IO™ Expandable Lumbar Interbody System6-1022-L2023-01-27
00810025487713IO™ Expandable Lumbar Interbody System6-1222-L2023-01-27
00810025487720IO™ Expandable Lumbar Interbody System6-1026-L2023-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157119089ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119096ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119102ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119119ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119126ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119133ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119140ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119157ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119164ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119171ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119188ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119195ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119201ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119218ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119225ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119232ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119249ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119256ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119263ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119270ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119287ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119294ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119300ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119317ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119324ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119331ZAVATION SCREWZavation LLCNKB2026-10-05
00197157119348ZAVATION SCREWZavation LLCNKB2026-10-05
00197157118280ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118297ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118303ZAVATION SCREWZavation LLCNKB2026-10-01