FDA.reportPublic FDA data

Inion S-1™

Primary DI
06438408012235
Brand
Inion S-1™
Company
Inion Oy
Model
1
Catalog number
SPN-5201
Device description
4.5 x 14 mm screw (4 x)
Published
2023-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJBResorbable spinal intervertebral body fixation orthosis - plate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJBResorbable Spinal Intervertebral Body Fixation Orthosis - PlateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051821000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051821000INION S-1 BIODEGRADABLE ANTERIOR CERVICAL FUSION SYSTEMInion , Ltd.2005-11-25OJB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438408012235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438408012235064384080122356438408012235

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, 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 chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device is available in various types, including pedicle and transfacet, and is typically used in spinal discectomy and fusion procedures as a means to maintain the relative position of bone allografts or autografts.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
367994657
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438408012587Inion® Universal instruments2INS-90912026-05-11
06438408012037Inion Hexalon instrument2INS-92002026-05-06
06438408002397Inion Hexalon™ ACL/PCL Screw1ACL-41132022-08-26
06438408002403Inion Hexalon™ ACL/PCL Screw1ACL-41142022-08-26
06438408002410Inion Hexalon™ ACL/PCL Screw1ACL-41152022-08-26
06438408002427Inion Hexalon™ ACL/PCL Screw1ACL-41012022-08-26
06438408002434Inion Hexalon™ ACL/PCL Screw1ACL-41022022-08-26
06438408002441Inion Hexalon™ ACL/PCL Screw1ACL-41032022-08-26
06438408002458Inion Hexalon™ ACL/PCL Screw1ACL-41042022-08-26
06438408002465Inion Hexalon™ ACL/PCL Screw1ACL-41052022-08-26
06438408002472Inion Hexalon™ ACL/PCL Screw1ACL-41062022-08-26
06438408002489Inion Hexalon™ ACL/PCL Screw1ACL-41072022-08-26
06438408002496Inion Hexalon™ ACL/PCL Screw1ACL-41082022-08-26
06438408002502Inion Hexalon™ ACL/PCL Screw1ACL-41092022-08-26
06438408002519Inion Hexalon™ ACL/PCL Screw1ACL-41122022-08-26
06438408012181Inion S-1™1SPN-50042023-12-19
06438408012198Inion S-1™1SPN-50052023-12-19
06438408012204Inion S-1™1SPN-50062023-12-19
06438408012211Inion S-1™1SPN-50072023-12-19
06438408012099Inion CPS™ instrumentation1INS-92752026-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850045446024SLT IVUS Support Crossing CatheterProvisio Medical, Inc.OJB2024-05-24
06438408006777Inion S-1™Inion OyOJB2023-12-19
06438408006784Inion S-1™Inion OyOJB2023-12-19
06438408006791Inion S-1™Inion OyOJB2023-12-19
06438408006876Inion S-1™Inion OyOJB2023-12-19
06438408006883Inion S-1™Inion OyOJB2023-12-19
06438408007019Inion S-2™Inion OyOJB2023-12-19
06438408007026Inion S-2™Inion OyOJB2023-12-19
06438408007033Inion S-2™Inion OyOJB2023-12-19
06438408007156Inion S-2™Inion OyOJB2023-12-19
06438408007163Inion S-2™Inion OyOJB2023-12-19
06438408012143Inion S-1™Inion OyOJB2023-12-19
06438408012150Inion S-1™Inion OyOJB2023-12-19
06438408012167Inion S-1™Inion OyOJB2023-12-19
06438408012174Inion S-1™Inion OyOJB2023-12-19
06438408012181Inion S-1™Inion OyOJB2023-12-19
06438408012198Inion S-1™Inion OyOJB2023-12-19
06438408012204Inion S-1™Inion OyOJB2023-12-19
06438408012211Inion S-1™Inion OyOJB2023-12-19
06438408012228Inion S-1™Inion OyOJB2023-12-19
06438408012242Inion S-1™Inion OyOJB2023-12-19
06438408012259Inion S-1™Inion OyOJB2023-12-19
06438408012266Inion S-1™Inion OyOJB2023-12-19
06438408012273Inion S-1™Inion OyOJB2023-12-19
06438408012280Inion S-1™Inion OyOJB2023-12-19
06438408012297Inion S-1™Inion OyOJB2023-12-19
06438408012303Inion S-1™Inion OyOJB2023-12-19
06438408012310Inion S-2™Inion OyOJB2023-12-19
06438408012327Inion S-2™Inion OyOJB2023-12-19
06438408006807Inion S-1™Inion OyOJB2023-12-19