Data / Medical devices / United States / Tedan Surgical Innovations, Inc.
Tedan Surgical Innovations, Inc.: FDA-registered device maker in Sugar Land, TX, United States, 2 510(k) clearances
Tedan Surgical Innovations, Inc. is registered with the FDA (registration 3005726885) in Sugar Land, TX, United States. It lists 20 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 20, 2017. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005726885
- Address
- 12320 Cardinal Meadow Drive Suite #150, Sugar Land, TX, United States, 77478
- Owner or operator
- TEDAN SURGICAL INNOVATIONS, INC. (9086980)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- May 9, 2006
- Registered through
- 2026
- Brand names listed
- BONE TAMP, CALIPERS FOR MEASURING BO, DISTRACTION SCREW, DRILL GUIDE, DRIVER, SURGICAL, PIN, ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY, GAUGE, DEPTH, HOOK, SURGICAL, GENERAL & PLASTIC SURGERY and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Caliper | KTZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Curette, Surgical, General Use | FZS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Driver, Surgical, Pin | GFC | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Holder, Camera, Surgical | FXR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Neurosurgical Nerve Locator | PDQ | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Operating Room Accessories Table Tray | FWZ | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Probe | HXB | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rasp | HTR | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor, Fiberoptic | FDG | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Retractor, Self-Retaining, For Neurosurgery | GZT | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Rongeur | HTX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 20, 2017 | K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems | GZT | Substantially Equivalent | Tedan Surgical Innovations, LLC | accessdata.fda.gov |
| September 25, 2014 | K140088 | PHANTOM XL INSULATED DILATORS | PDQ | Substantially Equivalent | Tedan Surgical Innovations, LLC | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 15, 2020 | 85830 | Class II | Terminated | 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine. | Lack of pouch seal. Product is labelled as sterile. | accessdata.fda.gov |
| July 16, 2019 | 85360 | Class II | Terminated | 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 general use intende | There was incorrect raw material used in the production of the identified lot. | accessdata.fda.gov |
| February 18, 2019 | 84252 | Class II | Terminated | 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 approach to the cervic | The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients. | accessdata.fda.gov |
| June 11, 2012 | 62899 | Class II | Terminated | 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, 110mm, 120mm, 130mm, | This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer ster | accessdata.fda.gov |
Compare with other makers
- All makers of Rongeur
- All makers of Tray, Surgical, Instrument
- All makers of Hook, Surgical, General & Plastic Surgery
- All makers of Probe
- All makers of Elevator, Surgical, General & Plastic Surgery
- All makers of Retractor, Fiberoptic
Updated March 20, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.