FDA Registration
Active
🇺🇸 United States
TEDAN SURGICAL INNOVATIONS, INC.
Reg #: 3005726885
·
FEI: 3005726885
·
Expires 2026
Products
19
Proprietary Names
22
Establishment Types
2
Classifications
19
Registration Details
- Registration Name
- TEDAN SURGICAL INNOVATIONS, INC.
- Registration Number
- 3005726885
- FEI Number
- 3005726885
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 12320 Cardinal Meadow Drive, Suite #150
- City
- Sugar Land
- State
- TX
- ZIP
- 77478
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140088
Owner / Operator
- Firm Name
- TEDAN SURGICAL INNOVATIONS, INC.
- Operator Number
- 9086980
- Address
- 12320 Cardinal Meadow Drive, Suite #150
- City
- Sugar Land
- State
- TX
- Postal Code
- 77478
- Country
- US
- Correspondent
- Lynne - Davies
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Probe | HXB | Class 1 | Orthopedic | No | 2012-12-20 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2007-11-23 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2008-12-10 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2006-05-09 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2007-11-23 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2014-11-21 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2007-11-23 |
| Retractor, Fiberoptic | FDG | Class 1 | Gastroenterology, Urology | No | 2009-12-15 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2008-12-10 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2008-12-10 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2008-12-10 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2014-06-02 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2006-05-09 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2008-12-10 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2023-10-10 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2008-12-10 |
| Retractor, Self-Retaining, For Neurosurgery | GZT | Class 2 | Neurology | No | 2017-05-25 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-05-09 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2008-12-10 |
Proprietary Names
PROBE
INSTRUMENT TRAY
ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY
VARIOUS TYPES OF RETRACT
RETRACTOR
PHANTOM XL INSULATED DILATORS
SURGICAL CURETTE
PHANTOM ML LIGHT CABLE
DRIVER, SURGICAL, PIN
MDE - Arm
SCREWDRIVER
INSTRUMENTS, SURGICAL, CARDIOVASCULAR
ULTRA VISION RETRACTOR SYSTEM
CALIPERS FOR MEASURING BO
RONGEUR
RASP
GAUGE, DEPTH
Phantom Fukushima/Mastability Systems
BONE TAMP
DISTRACTION SCREW
DRILL GUIDE
HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device