TeDan Surgical Innovations LLC
FDA Regulatory Profile
TeDan Surgical Innovations LLC appears in FDA public data with 13 recalls, 4 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2528-2020, Class II) was initiated on May 15, 2020. Its most recent 510(k) clearance was granted on April 26, 2026.
Summary
- Total Recalls
- 13
- 510(k) Clearances
- 4
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2528-2020 | Class II | PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used | May 15, 2020 |
| Z-2525-2020 | Class II | 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction i | May 15, 2020 |
| Z-2526-2020 | Class II | PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distra | May 15, 2020 |
| Z-2524-2020 | Class II | 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction i | May 15, 2020 |
| Z-2530-2020 | Class II | PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage: intended to be use | May 15, 2020 |
| Z-2527-2020 | Class II | PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distra | May 15, 2020 |
| Z-2529-2020 | Class II | PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used | May 15, 2020 |
| Z-1845-2020 | Class II | Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product U | July 16, 2019 |
| Z-1505-2020 | Class II | DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intende | February 18, 2019 |
| Z-1504-2020 | Class II | D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and | February 18, 2019 |
| Z-1503-2020 | Class II | D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and | February 18, 2019 |
| Z-1506-2020 | Class II | DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intende | February 18, 2019 |
| Z-2385-2012 | Class II | Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgi | June 11, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) | April 26, 2026 |
| K231691 | Phantom XL Insulated Dilators | June 29, 2023 |
| K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems | March 20, 2017 |
| K140088 | PHANTOM XL INSULATED DILATORS | September 25, 2014 |