Creed Ortholucent Implants F1-0825-028S

GUDID 18435711000091

CREED Cannulated Screws / Headless Compression / thread 8mm / 2.5 x 28mm

Glw, Inc.

Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)

• Primary Device ID: 18435711000091
• NIH Device Record Key: fc009ca4-80d0-4c1a-805d-68888bfd8f46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Creed Ortholucent Implants
• Version Model Number: F1-0825-028S
• Catalog Number: F1-0825-028S
• Company DUNS: 081102081
• Company Name: Glw, 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: true
• 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

• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter
• Length: 28 Millimeter
• Outer Diameter: 2.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	18435711000091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200291

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2024-02-08
• Device Publish Date: 2024-01-31

On-Brand Devices [Creed Ortholucent Implants]

• 18435711001913: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 120mm
• 18435711001906: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 115mm
• 18435711001890: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 110mm
• 18435711001883: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 105mm
• 18435711001876: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 100mm
• 18435711001869: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 95mm
• 18435711001852: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 90mm
• 18435711001845: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 85mm
• 18435711001838: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 80mm
• 18435711001821: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 75mm
• 18435711001814: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 70mm
• 18435711001807: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 65mm
• 18435711001791: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 60mm
• 18435711001784: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 55mm
• 18435711001777: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 50mm
• 18435711001760: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 48mm
• 18435711001753: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 46mm
• 18435711001746: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 44mm
• 18435711001739: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 42mm
• 18435711001722: CREED Cannulated Screws / Headed / Thread 32mm / 7.4 x 40mm
• 18435711001715: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 120mm
• 18435711001708: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 115mm
• 18435711001692: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 110mm
• 18435711001685: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 105mm
• 18435711001678: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 100mm
• 18435711001661: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 95mm
• 18435711001654: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 90mm
• 18435711001647: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 85mm
• 18435711001630: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 80mm
• 18435711001623: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 75mm
• 18435711001616: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 70mm
• 18435711001609: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 65mm
• 18435711001593: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 60mm
• 18435711001586: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 55mm
• 18435711001579: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 50mm
• 18435711001562: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 48mm
• 18435711001555: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 46mm
• 18435711001548: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 44mm
• 18435711001531: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 42mm
• 18435711001524: CREED Cannulated Screws / Headed / Thread 19mm / 7.4 x 40mm
• 18435711001517: CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 120mm
• 18435711001500: CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 115mm
• 18435711001494: CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 110mm
• 18435711001487: CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 105mm
• 18435711001470: CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 100mm
• 18435711001463: CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 95mm
• 18435711001456: CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 90mm
• 18435711001449: CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 85mm
• 18435711001432: CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 80mm
• 18435711001425: CREED Cannulated Screws / Headless Compression / Thread 32mm / 7.4 x 75mm