| Primary Device ID | 00889795062475 |
| NIH Device Record Key | 4e405d4b-ad01-49e0-966c-798cb3c5dbab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | APEX 3D Total Ankle Replacement System |
| Version Model Number | P10-921-TLR0 |
| Catalog Number | P10-921-TLR0 |
| Company DUNS | 042961576 |
| Company Name | PARAGON 28, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00889795062475 [Primary] |
| HSN | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889795062475]
Moist Heat or Steam Sterilization
[00889795062475]
Moist Heat or Steam Sterilization
[00889795062475]
Moist Heat or Steam Sterilization
[00889795062475]
Moist Heat or Steam Sterilization
[00889795062475]
Moist Heat or Steam Sterilization
[00889795062475]
Moist Heat or Steam Sterilization
[00889795062475]
Moist Heat or Steam Sterilization
[00889795062475]
Moist Heat or Steam Sterilization
[00889795062475]
Moist Heat or Steam Sterilization
[00889795062475]
Moist Heat or Steam Sterilization
[00889795062475]
Moist Heat or Steam Sterilization
[00889795062475]
Moist Heat or Steam Sterilization
[00889795062475]
Moist Heat or Steam Sterilization
[00889795062475]
Moist Heat or Steam Sterilization
[00889795062475]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-23 |
| Device Publish Date | 2020-12-15 |
| 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 |