AccessGUDID - DEVICE: Inion S-1™ (M224SPN50059)

GUDID

Device Identifier (DI) Information

Brand Name: Inion S-1™
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SPN-5005
Company Name: Inion Oy

Primary DI Number: M224SPN50059
Issuing Agency: HIBCC
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 367994657 *Terms of Use

Device Description: Plate, 27 x 19 x 0.8 mm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46652	Spinal fixation plate, bioabsorbable	A 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OJB	Resorbable spinal intervertebral body fixation orthosis - plate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051821	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2ade3f9d-20d5-4360-9a0d-da39dcbca659
Public Version Date: January 01, 2024
Public Version Number: 4
DI Record Publish Date: November 22, 2018

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

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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