Tyber Medical 204054317SM

GUDID M695204054317SM2Q

Tyber Medical, LLC

Intervertebral-body internal spinal fixation system

• Primary Device ID: M695204054317SM2Q
• NIH Device Record Key: df58b1a1-9dcd-4d5f-b616-6da1e2d05721
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyber Medical
• Version Model Number: Fixed Screws 4.25 mm OD x 17 mm
• Catalog Number: 204054317SM
• Company DUNS: 010968002
• Company Name: Tyber Medical, LLC
• Device Count: 2
• 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: 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M695204054317SM1 [Unit of Use]
HIBCC	M695204054317SM2Q [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103068

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2025-08-15
• Device Publish Date: 2018-02-02

On-Brand Devices [Tyber Medical]

• M695409653951F: Headed Cannulated Screw Long Ø6.5mm x 95mm
• M6954096538019: Headed Cannulated Screw Long Ø6.5mm x 80mm
• M69520405844S1: ACP Level 4, 84 mm
• M69520405804S1: ACP Level 4, 81 mm
• M69520405764S1: ACP Level 4, 76 mm
• M69520405724S1: ACP Level 4, 72 mm
• M69520405713S1: ACP Level 3, 71 mm
• M69520405684S1: ACP Level 4, 68 mm
• M69520405683S1: ACP Level 3, 68 mm
• M69520405653S1: ACP Level 3, 65 mm
• M69520405644S1: ACP Level 4, 64 mm
• M69520405623S1: ACP Level 3, 62 mm
• M69520405604S1: ACP Level 4, 60 mm
• M69520405593S1: ACP Level 3, 59 mm
• M69520405563S1: ACP Level 3, 56 mm
• M69520405533S1: ACP Level 3, 53 mm
• M69520405502S1: ACP Level 3, 50 mm
• M69520405482S1: ACP Level 2, 48 mm
• M69520405452S1: ACP Level 2, 45 mm
• M695204054317SM2Q: Fixed Screws 4.25 mm OD x 17 mm
• M695204054316SM2Q: Fixed Screws 4.25 mm OD x 16 mm
• M695204054315SM2Q: Fixed Screws 4.25 mm OD x 15 mm
• M695204054314SM2Q: Fixed Screws 4.25 mm OD x 14 mm
• M69520405422S1: ACP Level 2, 42 mm
• M695204054217SM2Q: Variable Screws 4.25 mm OD x 17 mm
• M695204054216SM2Q: Variable Screws 4.25 mm OD x 16 mm
• M695204054215SM2Q: Variable Screws 4.25 mm OD x 15 mm
• M695204054214SM2Q: Variable Screws 4.25 mm OD x 14 mm
• M695204054117SM2Q: Fixed Screws 4.00 mm OD x 17 mm
• M695204054116SM2Q: Fixed Screws 4.00 mm OD x 16 mm
• M695204054115SM2Q: Fixed Screws 4.00 mm OD x 15 mm
• M695204054114SM2Q: Fixed Screws 4.00 mm OD x 14 mm
• M695204054017SM2Q: Variable Screws 4.00 mm OD x 17 mm
• M695204054015SM2Q: Variable Screws 4.00 mm OD x 15 mm
• M695204054014SM2Q: Variable Screws 4.00 mm OD x 14 mm
• M69520405392S1: ACP Level 2, 39 mm
• M69520405362S1: ACP Level 2, 36 mm
• M69520405332S1: ACP Level 2, 33 mm
• M69520405302S1: ACP Level 2, 30 mm
• M69520405282S1: ACP Level 2, 28 mm
• M69520405281S1: ACP Level 1, 28 mm
• M69520405261S1: ACP Level 1, 26 mm
• M69520405241S1: ACP Level 1, 24 mm
• M69520405221S1: ACP Level 1, 22 mm
• M69520405201S1: ACP Level 1, 20 mm
• M69520405181S1: ACP Level 1, 18 mm
• M69520405161S1: ACP Level 1, 16 mm
• M69520405141S1: ACP Level 1, 14 mm
• M695204014016SM2Q: Variable Screws 4.00 mm OD x 16 mm