FDA.reportPublic FDA data

EUROPA™ Pedicle Screw

Primary DI
00811638031256
Brand
EUROPA™ Pedicle Screw
Company
MIRUS LLC
Model
1-2-8545C
Device description
Ø8.5 X 45mm EUROPA™ Pedicle Screw, Cannulated
Published
2023-03-06
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
00811638031256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811638031256008116380312568116380312560811638031256

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

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
00197157059521ZAVATION RODZavation LLCNKB2026-06-04
00197157059538ZAVATION RODZavation LLCNKB2026-06-04
00197157059545ZAVATION RODZavation LLCNKB2026-06-04
00197157059552ZAVATION RODZavation LLCNKB2026-06-04
00197157059569ZAVATION RODZavation LLCNKB2026-06-04
00197157059576ZAVATION RODZavation LLCNKB2026-06-04
00197157059583ZAVATION RODZavation LLCNKB2026-06-04
00197157059590ZAVATION RODZavation LLCNKB2026-06-04
00197157059606ZAVATION RODZavation LLCNKB2026-06-04
00197157059613ZAVATION RODZavation LLCNKB2026-06-04
00197157059620ZAVATION RODZavation LLCNKB2026-06-04
00197157059637ZAVATION RODZavation LLCNKB2026-06-04
00197157059644ZAVATION RODZavation LLCNKB2026-06-04
00197157059651ZAVATION RODZavation LLCNKB2026-06-04
00197157059668ZAVATION RODZavation LLCNKB2026-06-04
00197157059491ZAVATION RODZavation LLCNKB2026-06-03
00197157059507ZAVATION RODZavation LLCNKB2026-06-03
00197157059514ZAVATION RODZavation LLCNKB2026-06-03
00840311244874Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244874Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244874Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244881Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244881Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244881Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244904Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03
00840311244904Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244904Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244928Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.NKB2026-06-03
00840311244928Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNH2026-06-03
00840311244928Streamline MIS Spinal Fixation SystemXtant Medical Holdings, Inc.MNI2026-06-03