APEX 3D S Total Ankle Replacement System P11-900-0004

GUDID 00889795146182

Short Stem Tibia System, Instrument, Drill Caddy Lid

PARAGON 28, INC.

Device sterilization/disinfection container, reusable

• Primary Device ID: 00889795146182
• NIH Device Record Key: 9ace4b35-83fc-4c0f-a043-6394d20c5da2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APEX 3D S Total Ankle Replacement System
• Version Model Number: P11-900-0004
• Catalog Number: P11-900-0004
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
GS1	00889795146182 [Primary]

FDA Product Code

• FSM: TRAY, SURGICAL, INSTRUMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-04
• Device Publish Date: 2025-02-24

On-Brand Devices [APEX 3D S Total Ankle Replacement System]

• 00889795140715: Short Stem Tibia System, Instrument Case, Lid
• 00889795140708: Short Stem Tibia System, Instrument Case, Base
• 00889795140692: Short Stem Tibia System, Drill Caddy
• 00889795140685: Short Stem Tibia System, Tray 2
• 00889795140678: Short Stem Tibia System, Tray 1
• 00889795140661: Apex 3D-S TAR X-ray Templates Packet
• 00889795140647: Short Stem Tibia, Instrument, Drill Wrench
• 00889795140616: Short Stem Tibia, Instrument, Right Angle Drill
• 00889795140609: Short Stem Tibia, Instrument, Manual Drill
• 00889795140593: Short Stem Tibia, Instrument, Linear Guide Rail
• 00889795140586: Short Stem Tibia, Instrument, Drill Bit, Tall, D12 x H14
• 00889795140579: Short Stem Tibia, Instrument, Drill Bit, Pilot, D12 x H7.5
• 00889795140562: Short Stem Tibia, Instrument, Drill Bit, Tall, D10.5 x H14
• 00889795140555: Short Stem Tibia, Instrument, Drill Bit, Pilot, D10.5 x H7.5
• 00889795140548: Short Stem Tibia, Instrument, Drill Bit, Tall, D9 x H14
• 00889795140531: Short Stem Tibia, Instrument, Impaction Protector (Size 5+6)
• 00889795140524: Short Stem Tibia, Instrument, Impaction Protector (Size 3+4)
• 00889795140517: Short Stem Tibia, Instrument, Impaction Protector (Size 1+2)
• 00889795140494: Short Stem Tibia, Instrument, Forked Paddle, Flat
• 00889795140487: Short Stem Tibia, Instrument, Flat Paddle - 2
• 00889795140463: Short Stem Tibia, Instrument, Implantation Paddle
• 00889795140456: Short Stem Tibia, Instrument, Forked Paddle, Arc
• 00889795140449: Short Stem Tibia, Instrument, Trial Tibia, Tall Drill Guide, Size 6 - FLAT
• 00889795140432: Short Stem Tibia, Instrument, Trial Tibia, Tall Drill Guide, Size 5 - FLAT
• 00889795140425: Short Stem Tibia, Instrument, Trial Tibia, Tall Drill Guide, Size 4 - FLAT
• 00889795140418: Short Stem Tibia, Instrument, Trial Tibia, Tall Drill Guide, Size 3 - FLAT
• 00889795140401: Short Stem Tibia, Instrument, Trial Tibia, Tall Drill Guide, Size 2 - FLAT
• 00889795140395: Short Stem Tibia, Instrument, Trial Tibia, Tall Drill Guide, Size 1 - FLAT
• 00889795140388: Short Stem Tibia, Instrument, Tibia, Tall Drill Guide, Size 6 - ARC
• 00889795140371: Short Stem Tibia, Instrument, Tibia, Tall Drill Guide, Size 5 - ARC
• 00889795140364: Short Stem Tibia, Instrument, Tibia, Tall Drill Guide, Size 4 - ARC
• 00889795140357: Short Stem Tibia, Instrument, Tibia, Tall Drill Guide, Size 3 - ARC
• 00889795140340: Short Stem Tibia, Instrument, Tibia, Tall Drill Guide, Size 2 - ARC
• 00889795140333: Short Stem Tibia, Instrument, Tibia, Tall Drill Guide, Size 1 - ARC
• 00889795140326: Short Stem Tibia, Instrument, Trial Holder
• 00889795140319: Short Stem Tibia, Instrument, Tibial Docking Fixture, Sizes 5-6
• 00889795140302: Short Stem Tibia, Instrument, Tibial Docking Fixture, Sizes 3-4
• 00889795140296: Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 6 - FLAT
• 00889795140289: Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 5 - FLAT
• 00889795140272: Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 4 - FLAT
• 00889795140265: Short Stem Tibia, Instrument, Graft impactor - D12
• 00889795140258: Short Stem Tibia, Instrument, Graft impactor - D10.5
• 00889795140241: Short Stem Tibia, Instrument, Graft impactor - D9
• 00889795140234: Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 3 - FLAT
• 00889795140227: Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 2 - FLAT
• 00889795140210: Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 1 - FLAT
• 00889795140203: Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 6 - ARC
• 00889795140197: Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 5 - ARC
• 00889795140180: Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 4 - ARC
• 00889795140173: Short Stem Tibia, Instrument, Trial Tibia, Poly Trial, Size 3 - ARC