OrthoMesh

Basic Information

• Brand Name: OrthoMesh
• Primary DI: 20886982255959
• Version / Model: 804.006.02S
• Catalog Number: 80400602S
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2015-09-14
• Public Version: 6
• Public Version Date: 2024-01-03
• Public Version Status: Update
• Public Device Record Key: 96909c54-780d-4633-8352-a6e76dd00d24

Device Description

2.0MM RESORBABLE CORTEX SCREW 6MM FOR ORTHOMESH-STERILE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
HRS	PLATE, FIXATION, BONE	Orthopedic	888.3030	2
HWC	Screw, fixation, bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45039	Bioabsorbable orthopaedic bone screw	A small, threaded, implantable rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). There are several kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded. A "lag screw" can be any of these used to obtain compression across bone fragments.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H67980400602S0	HIBCC
Primary	20886982255959	GS1
Unit of Use	80886982255951	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K073115	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 77 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: High: 43 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: High: 110 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: .