GENESYS CROSSFT, HI-FI, LINVATEC SRS

Basic Information

• Brand Name: GENESYS CROSSFT, HI-FI, LINVATEC SRS
• Primary DI: 20845854034610
• Version / Model: CFBC-6502N
• Catalog Number: CFBC-6502N
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-17
• Public Version: 2
• Public Version Date: 2024-08-05
• Public Version Status: Update
• Public Device Record Key: f05c88ae-78e3-4b70-9ab7-c3fa0f786246

Device Description

GENESYS CrossFT 6.5 mm Suture Anchor, w/2 Hi-Fi #2 (5 metric) Sutures w/Needles

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: MR Safe
• 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
MAI	Fastener, fixation, biodegradable, soft tissue	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45061	Tendon/ligament bone anchor, bioabsorbable	A bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30845854034617	GS1	Carton	1	In Commercial Distribution
Primary	20845854034610	GS1
Previous	10845854034613	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K101100	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: High: 104 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: KEEP DRY