ROG Cuff Anchor 10-1301

GUDID 00855152006048

ROG 5.5mm Cuff Anchor w 3 x #2 UHMWPE suture

Rog Sports Medicine, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00855152006048
• NIH Device Record Key: 1f02109c-f632-4682-b815-dd069b2e2fb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROG Cuff Anchor
• Version Model Number: 10-1301
• Catalog Number: 10-1301
• Company DUNS: 006254430
• Company Name: Rog Sports Medicine, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855152006048 [Primary]
GS1	10855152006045 [Package]; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113299

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, 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: 2021-03-23
• Device Publish Date: 2021-03-15

Devices Manufactured by Rog Sports Medicine, Inc.

• 00855152006048 - ROG Cuff Anchor: 2021-03-23ROG 5.5mm Cuff Anchor w 3 x #2 UHMWPE suture
• 00855152006048 - ROG Cuff Anchor: 2021-03-23 ROG 5.5mm Cuff Anchor w 3 x #2 UHMWPE suture
• 10855152006038 - RoG Rope: 2019-02-07 UHMWPE #2 Suture
• 00855152006000 - RoG Cuff Anchor 5.5mm: 2018-07-06 5.5mm suture anchor with 2x 36" UHMWPE #2 suture
• 10855152006014 - RoG 5.5mm Knotless Suture Anchor: 2018-07-06 RoG 5.5mm Knotless Suture Anchor
• 10855152006021 - RoG Single: 2018-07-06 2.9mm Suture Anchor with 2x 36" UHMWPE #2 suture