FDA.reportPublic FDA data

Inion S-1™

Primary DI
06438408012198
Brand
Inion S-1™
Company
Inion Oy
Model
1
Catalog number
SPN-5005
Device description
Plate, 27 x 19 x 0.8 mm
Published
2023-12-19
Public version status
Update
Distribution status
Not 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
06438408012198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438408012198064384080121986438408012198

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, bioabsorbableA small, implantable, non-customized sheet of firm material intended to be attached to the spine with screws for spinal immobilization; it is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., a degradable polymer). The device is typically used in spinal discectomy and fusion procedures 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
06438408012204Inion S-1™1SPN-50062023-12-19
06438408012211Inion S-1™1SPN-50072023-12-19
06438408012099Inion CPS™ instrumentation1INS-92752026-01-21
06438408012105Inion CPS™ instrumentation1INS-92762026-01-21

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
06438408012204Inion S-1™Inion OyOJB2023-12-19
06438408012211Inion S-1™Inion OyOJB2023-12-19
06438408012228Inion S-1™Inion OyOJB2023-12-19
06438408012235Inion 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