ecoFIX EPAV255CLA

GUDID 03760304680601

Ø 5.5 mm anchor mounted on reel with 2 round sutures

S.B.M

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 03760304680601
• NIH Device Record Key: 25a16bb0-4bf8-497a-8aa3-1e2a116a20d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ecoFIX
• Version Model Number: ecoFIX® Ø 5.5 mm Threaded Double-Loaded Suture Anc
• Catalog Number: EPAV255CLA
• Company DUNS: 772462123
• Company Name: S.B.M
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760304680601 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231787

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, Soft Tissue

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-19
• Device Publish Date: 2023-09-11

On-Brand Devices [ecoFIX]

• 03760304680595: Ø 4.5 mm anchor mounted on reel with 2 round sutures
• 03760304680618: Ø 6.5 mm anchor mounted on reel with 2 round sutures
• 03760304680601: Ø 5.5 mm anchor mounted on reel with 2 round sutures
• 03760304681127: Screwdriver to be used with diameter 5.5 mm and 6.5 mm ecoFIX anchors for rotator cuff repair.
• 03760304681110: Screwdriver to be used with diameter 4.5 mm ecoFIX anchors for rotator cuff repair.
• 03760304681288: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a
• 03760304681271: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a
• 03760304681264: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a
• 03760304681257: Surgical Instrument Set consisting of reusable surgical instruments intended to be used during a