ORION WEDGE

Basic Information

• Brand Name: ORION WEDGE
• Primary DI: 00841742142159
• Version / Model: HTR-04-224310
• Catalog Number: HTR-04-224310
• Company Name: HNM TOTAL RECON LLC
• Labeler DUNS: 080024940
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-30
• Public Version: 4
• Public Version Date: 2021-06-08
• Public Version Status: Update
• Public Device Record Key: 8bfb28b6-739f-48c8-93ee-14012aec2c15

Device Description

ORION Ti PEEK EVANS Wedge - 22x22x10mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PLF	Bone Wedge	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61330	Polymeric 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) following osteotomy to help facilitate bone fusion and alignment; it is typically 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 synthetic polymer [e.g., polyetheretherketone (PEEK)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841742142159	GS1

Premarket Submissions

Submission Number	Supplement Number
K150394	000