Company ยท US
TeDan Surgical Innovations LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2026. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (1 in 12 months)
13recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 26, 2026 | K253580 | Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S); Sterile, Insulated Dilator, 20mm (MDT-0469S) Tedan Surgical Innovations | PDQ |
| Jun 29, 2023 | K231691 | Phantom XL Insulated Dilators TeDan Surgical Innovations, Inc. | GXZ |
| Mar 20, 2017 | K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems Tedan Surgical Innovations, LLC | GZT |
| Sep 25, 2014 | K140088 | PHANTOM XL INSULATED DILATORS Tedan Surgical Innovations, LLC | PDQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 15, 2020 | TeDan Surgical Innovations LLC PHANTOM CS QUICK START DISTRACTION SCREW, 16
MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. Terminated |
LXH | None listed |
| May 15, 2020 | TeDan Surgical Innovations LLC PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. Terminated |
LXH | None listed |
| May 15, 2020 | TeDan Surgical Innovations LLC PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. Terminated |
LXH | None listed |
| May 15, 2020 | TeDan Surgical Innovations LLC PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE,
5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. Terminated |
LXH | None listed |
| May 15, 2020 | TeDan Surgical Innovations LLC PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE,
5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. Terminated |
LXH | None listed |
| May 15, 2020 | TeDan Surgical Innovations LLC 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. Terminated |
LXH | None listed |
| May 15, 2020 | TeDan Surgical Innovations LLC 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. Terminated |
LXH | None listed |
| Jul 16, 2019 | TeDan Surgical Innovations LLC Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: TK-1110 - Product Usage: TSI Fukushima Suction Tubes are nonpowered, hand-held reusable manual surgical instruments for Terminated |
GEA | None listed |
| Feb 18, 2019 | TeDan Surgical Innovations LLC DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers. Terminated |
LXH | None listed |
| Feb 18, 2019 | TeDan Surgical Innovations LLC DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers. Terminated |
LXH | None listed |
| Feb 18, 2019 | TeDan Surgical Innovations LLC D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior ap Terminated |
LXH | None listed |
| Feb 18, 2019 | TeDan Surgical Innovations LLC D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior ap Terminated |
LXH | None listed |
| Sep 14, 2012 | Tedan Surgical Innovations Llc Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, Terminated |
LXH | None listed |