N/A

GUDID M695M9402320

Tyber Medical, LLC

Orthopaedic bone screw (non-sliding)

• Primary Device ID: M695M9402320
• NIH Device Record Key: c17e6729-8657-4227-8a01-f12924dd83a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: M9-40232
• Company DUNS: 010968002
• Company Name: Tyber Medical, LLC
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M695M9402320 [Primary]

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-08-15
• Device Publish Date: 2019-02-06

Devices Manufactured by Tyber Medical, LLC

• 00196449033638 - Anatomic Access LLIF: 2025-12-18 Anatomic Access LLIF, Cobb, Sharp, 22mm
• 00196449033669 - Anatomic Access LLIF: 2025-12-18 Anatomic Access LLIF, Cobb, Angled CC-15° OUT, 18mm
• 00196449033683 - Anatomic Access LLIF: 2025-12-18 Anatomic Access LLIF, Cobb, Angled CC-15° OUT, Sharp, 18mm
• 00196449035007 - Anatomic Access LLIF: 2025-12-18 Anatomic Access LLIF, Straight Cup Curette, 7mm
• 00196449035014 - Anatomic Access LLIF: 2025-12-18 Anatomic Access LLIF, Cup Curette, 7mm, 45° Pull
• 00196449035021 - Anatomic Access LLIF: 2025-12-18 Anatomic Access LLIF, Cup Curette, 7mm, Angled CC-15° IN
• 00196449035038 - Anatomic Access LLIF: 2025-12-18 Anatomic Access LLIF, Cup Curette, 7mm, 45° Pull, Angled CC-15°, LEFT
• 00196449035045 - Anatomic Access LLIF: 2025-12-18 Anatomic Access LLIF, Cup Curette, 7mm, Angled CC-15° OUT