FPS Locking Screw 3.5mm CLS3.5-28

GUDID 00842188105937

Locking Screw 3.5, 28mm

TRIMED, INCORPORATED

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00842188105937
• NIH Device Record Key: f0dfd046-7c47-407f-8076-36da09f21dac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FPS Locking Screw 3.5mm
• Version Model Number: CLS3.5-28
• Catalog Number: CLS3.5-28
• Company DUNS: 138041277
• Company Name: TRIMED, INCORPORATED
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com
• Phone: +1(661)255-7406
• Email: info@trimedortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842188105937 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050681

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

[00842188105937]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-07

On-Brand Devices [FPS Locking Screw 3.5mm]

• 00842188105968: Locking Screw 3.5, 34mm
• 00842188105951: Locking Screw 3.5, 32mm
• 00842188105944: Locking Screw 3.5, 30mm
• 00842188105937: Locking Screw 3.5, 28mm
• 00842188105920: Locking Screw 3.5, 26mm
• 00842188105913: Locking Screw 3.5, 24mm
• 00842188105906: Locking Screw 3.5, 22mm
• 00842188105890: Locking Screw 3.5, 20mm
• 00842188105883: Locking Screw 3.5, 18mm
• 00842188105876: Locking Screw 3.5, 16mm
• 00842188105869: Locking Screw 3.5, 14mm
• 00842188105852: Locking Screw 3.5, 12mm