APEX 3D Total Ankle Replacement System P10-101-BL6S-S

GUDID 00889795097521

APEX 3D™ Tibia, Flat, Left, Size 6, Standard, 3DP

PARAGON 28, INC.

Fixed-bearing total ankle prosthesis

• Primary Device ID: 00889795097521
• NIH Device Record Key: be34b2ca-7a5a-4d9b-9cce-5e08fabb584c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APEX 3D Total Ankle Replacement System
• Version Model Number: P10-101-BL6S-S
• Catalog Number: P10-101-BL6S-S
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 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	00889795097521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192994

FDA Product Code

• HSN: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-23
• Device Publish Date: 2020-12-15

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

• 00889795099563: APEX 3D-PS Total Ankle Replacement System, Talus Impaction Handle, Pad
• 00889795099051: APEX 3D-PS Total Ankle Replacement System, Case Lid
• 00889795099044: APEX 3D-PS Total Ankle Replacement System, Case Base
• 00889795099013: APEX 3D-PS Total Ankle Replacement System, Small Tray
• 00889795099006: APEX 3D-PS Total Ankle Replacement System, Large Instrumentation, Tray
• 00889795098993: APEX 3D-PS Total Ankle Replacement System, Impaction, Tray
• 00889795098986: APEX 3D-PS Total Ankle Replacement System, Talus Trialing, Tray
• 00889795098979: APEX 3D-PS Total Ankle Replacement System, Tibia Trialing, Tray
• 00889795098962: APEX 3D-PS Total Ankle Replacement System, Resection, Tray
• 00889795098955: APEX 3D-PS Total Ankle Replacement System, Alignment, Tray
• 00889795098931: APEX 3D-PS Total Ankle Replacement System, Poly Insertion Tool
• 00889795097538: APEX 3D™ Tibia, Flat, Right, Size 6, Standard, 3DP
• 00889795097521: APEX 3D™ Tibia, Flat, Left, Size 6, Standard, 3DP
• 00889795097514: APEX 3D™ Tibia, Arc, Right, Size 6, Standard, 3DP
• 00889795097507: APEX 3D™ Tibia, Arc, Left, Size 6, Standard, 3DP
• 00889795076410: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 20MM, NEUTRAL
• 00889795076397: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 18MM, NEUTRAL
• 00889795076373: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 16MM, NEUTRAL
• 00889795076359: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 14MM, NEUTRAL
• 00889795076335: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 12MM, NEUTRAL
• 00889795076328: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 11MM, NEUTRAL
• 00889795076311: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 10MM, NEUTRAL
• 00889795076304: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 9MM, NEUTRAL
• 00889795076298: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 8MM, NEUTRAL
• 00889795076281: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 7MM, NEUTRAL
• 00889795076274: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 5 x 6MM, NEUTRAL
• 00889795075062: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 20MM, NEUTRAL
• 00889795075048: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 18MM, NEUTRAL
• 00889795075024: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 16MM, NEUTRAL
• 00889795075000: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 14MM, NEUTRAL
• 00889795074980: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 12MM, NEUTRAL
• 00889795074973: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 11MM, NEUTRAL
• 00889795074966: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 10MM, NEUTRAL
• 00889795074959: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 9MM, NEUTRAL
• 00889795074942: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 8MM, NEUTRAL
• 00889795074935: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 7MM, NEUTRAL
• 00889795074928: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 4 x 6MM, NEUTRAL
• 00889795073716: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 20MM, NEUTRAL
• 00889795073693: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 18MM, NEUTRAL
• 00889795073679: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 16MM, NEUTRAL
• 00889795073655: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 14MM, NEUTRAL
• 00889795073631: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 12MM, NEUTRAL
• 00889795073624: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 11MM, NEUTRAL
• 00889795073617: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 10MM, NEUTRAL
• 00889795073600: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 9MM, NEUTRAL
• 00889795073594: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 8MM, NEUTRAL
• 00889795073587: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 7MM, NEUTRAL
• 00889795073570: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 3 x 6MM, NEUTRAL
• 00889795072368: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 20MM, NEUTRAL
• 00889795072344: APEX 3D™ Cross-linked Vitamin E POLY, SIZE 2 x 18MM, NEUTRAL