AccessGUDID - DEVICE: OsteoSinter® EVANS wedge 18W x 18L x 8H mm (08437019951467)

GUDID

Device Identifier (DI) Information

Brand Name: OsteoSinter® EVANS wedge 18W x 18L x 8H mm
Version or Model: P00200B1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AMES MEDICAL PROSTHETIC SOLUTIONS S.A.

Primary DI Number: 08437019951467
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 468566411 *Terms of Use

Device Description: No description.

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?
61617	Metallic osteotomy fusion cage, non-customized	A non-customized device intended to be implanted between the severed ends of a long bone (e.g., femur, tibia), or other bone (e.g., tarsal, carpel), following osteotomy to help facilitate bone fusion and alignment; it may be used with a plating fixation system and may be used in association with a bone substitute/graft. The device is typically designed as a small, wedge-shaped cylinder (or other geometric form) and is made of metal [e.g., titanium (Ti)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PLF	Bone Wedge

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K240461	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
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Do not use if package is damaged and consult instructions for use

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 425fd396-8953-4759-86ff-7f81c9d62e72
Public Version Date: March 24, 2025
Public Version Number: 1
DI Record Publish Date: March 14, 2025