FPS F25-019120

GUDID 00810040688768

Ø3.0/3.5/4.0 Plate Tack, Long

Tyber Medical LLC

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00810040688768
• NIH Device Record Key: 903d3d13-5e43-444b-8828-1edb62f0d881
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FPS
• Version Model Number: F25-019120
• Catalog Number: F25-019120
• 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

Customer Support Contacts

• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com
• Phone: +1(866)761-0933
• Email: mschenk@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810040688768 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-19
• Device Publish Date: 2022-12-15

On-Brand Devices [FPS]

• 00810040688683: Ø2.5 x 185mm Drill
• 00810040689055: Lapidus Targeting Screw Guide, Medial, Right
• 00810040689048: Lapidus Targeting Screw Guide, Medial, Left
• 00810040689031: MTP Targeting Screw Guide, Right
• 00810040689024: MTP Targeting Screw Guide, Left
• 00810040689017: Ø24mm Female Reamer
• 00810040689000: Ø22mm Female Reamer
• 00810040688997: Ø20mm Female Reamer
• 00810040688980: Ø18mm Female Reamer
• 00810040688973: Ø24mm Male Reamer
• 00810040688966: Ø22mm Male Reamer
• 00810040688959: Ø20mm Male Reamer
• 00810040688942: Ø18mm Male Reamer
• 00810040688935: 5th Met. Hook Plate Tamp
• 00810040688928: Drill Guide Handle
• 00810040688911: 5th Met. Avulsion Hook Plate Drill Guide, Right
• 00810040688904: 5th Met. Avulsion Hook Plate Drill Guide, Left
• 00810040688898: 5th Met. Cross Screw Drill Guide
• 00810040688881: 5th Met. Hook Plate Drill Guide, Right
• 00810040688874: 5th Met. Hook Plate Drill Guide, Left
• 00810040688867: Ø5.5 Drill Guide
• 00810040688850: Ø4.0 / 4.5 Drill Guide
• 00810040688843: Ø1.6 Wire Guide
• 00810040688836: Ratcheting AO Handle, Blue
• 00810040688829: Mini Fixed Handle, AO
• 00810040688812: Cartilage removal tool, 14mm
• 00810040688805: Cartilage removal tool, 8mm
• 00810040688799: Ø2.0mm Subchondral Drill
• 00810040688782: Plate Bending Pliers - Ø4.00 Tip
• 00810040688775: Plate Bending Pliers - Ø2.38 Tip
• 00810040688768: Ø3.0/3.5/4.0 Plate Tack, Long
• 00810040688751: Ø2.5/3.0 Plate Tack, Long
• 00810040688744: Ø2.0 Plate Tack
• 00810040688737: Ø3.0/3.5/4.0mm Depth Gauge Hook - 110mm
• 00810040688720: Ø3.0/3.5/4.0mm Depth Gauge Hook- 60mm
• 00810040688713: Ø2.0/2.5/3.0mm Depth Gauge Hook- 40mm
• 00810040688706: Depth Gauge Ø3.0/3.5/4.0mm - 60mm
• 00810040688690: Depth Gauge Ø2.0/2.5/3.0mm - 40mm
• 00810040688676: Ø2.5 x 125mm Drill
• 00810040688669: Ø2.0 x 125mm Drill
• 00810040688652: Ø1.8 x 125mm Drill
• 00810040688645: Ø1.5 x 115mm Drill
• 00810040688638: Ø3.5/4.0mm Variable and Fixed Angle Drill Guide
• 00810040688621: Ø3.0mm Variable and Fixed Angle Drill Guide
• 00810040688614: Ø3.0mm Variable and Fixed Angle Drill Guide - Mini-Frag
• 00810040688607: Ø2.5mm Variable and Fixed Angle Drill Guide
• 00810040688591: Ø2.0mm Variable and Fixed Angle Drill Guide
• 00810040688584: T15 Retention Driver
• 00810040688577: T8 Retention Driver
• 00810040688560: T6 Retention Driver