DEVICE: Inion S-2™ (M224SPN55019)

Device Identifier (DI) Information

Inion S-2™
1
In Commercial Distribution
SPN-5501
Inion Oy
M224SPN55019
HIBCC
October 01, 2026
1
367994657 *Terms of Use
6.0 x 25 mm screw
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46650 Spinal bone screw, bioabsorbable
A small, threaded, implantable rod with a screw head and drive intended 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). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used in spinal discectomy and fusion procedures as a means to maintain the relative position of bone allografts or autografts.
Active true
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
OJB Resorbable spinal intervertebral body fixation orthosis - plate
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K071810 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

feca05fe-b86c-4c61-b4f8-99888a2a1bef
September 11, 2024
7
March 26, 2018
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE