FDA Registration
Active
🇺🇸 United States
NVISION BIOMEDICAL TECHNOLOGIES, INC
Reg #: 3011301313
·
FEI: 3011301313
·
Expires 2026
Products
29
Proprietary Names
34
Establishment Types
2
Classifications
29
Registration Details
- Registration Name
- NVISION BIOMEDICAL TECHNOLOGIES, INC
- Registration Number
- 3011301313
- FEI Number
- 3011301313
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 12449 Silicon Dr
- City
- San Antonio
- State
- TX
- ZIP
- 78249
- Country
- US
Regulatory Submissions
- 510(k) Number
- K200428
Owner / Operator
- Firm Name
- Nvision Biomedical Technologies, Inc.
- Operator Number
- 10048243
- Address
- 12449 Silicon Drive
- City
- San Antonio
- State
- TX
- Postal Code
- 78249
- Country
- US
- Correspondent
- Anika Joseph-Smith
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2022-01-24 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2017-02-15 |
| Bone Wedge | PLF | Class 2 | Orthopedic | No | 2020-11-03 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-11-03 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-11-03 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2018-01-16 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2015-11-13 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2025-04-17 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-11-18 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-11-18 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2017-02-15 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2019-07-16 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2017-02-15 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2019-05-10 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2019-05-10 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-03-26 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2017-02-15 |
| Bender | HXW | Class 1 | Orthopedic | No | 2017-02-15 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2019-04-03 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2019-06-12 |
| Probe | HXB | Class 1 | Orthopedic | No | 2019-04-03 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2025-06-20 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2017-02-15 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2017-02-15 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2019-05-10 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2018-11-01 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2015-11-13 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2015-11-13 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2025-11-18 |
Proprietary Names
Multi-Drive Interference Screw System
nva
Trigon Wedge Fixation System
Boundary
Tamp
SnapHammer
Vector
Healix
Vector Hammertoe Correction System
3D Printed PEEK Interbody System
Subtalar & Lapidus Wedge
tangis
Javelin Tailor's Bunion Fixation System
Nvision
nvc
Focus Pedicle Screw System
nvp
Trigon
Radian MIS Bunion System
Trigon HA Stand-Alone Wedge Fixation System
Integral
Focus
Quantum Anterior Cervical Plate
Trigon Met Adductus
Healix Compression Screw System
VERTEX Nitinol Staple System
NVa, NVp, NVt Intervertebral Body Fusion Device
Impact
Caliber Intramedullary Fixation System
nvt
Tangis
FOCUS Pedical Screw System
Rasp
Trial, Inserter, Paddle Shaver, Slap Hammer, Distractor
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility