Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011301313

FEI Number

3011301313

Entity Name

NVISION BIOMEDICAL TECHNOLOGIES, INC

City/State/Country

San Antonio, TX, US

Establishment Address

12449 Silicon Dr, San Antonio, TX 78249, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Nvision Biomedical Technologies, Inc. (Owner Number: 10048243)

Owner / Operator Contact Address

12449 Silicon Drive, San Antonio, TX 78249, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K142328

PMA Number

N/A

All Registered 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 Healix Javelin Tailor's Bunion Fixation System tangis Nvision nvc Vector nvc Vector Focus Pedicle Screw System nvp Trigon Radian MIS Bunion System tangis Trigon HA Stand-Alone Wedge Fixation System Integral tangis Focus Quantum Anterior Cervical Plate Trigon Met Adductus Healix Compression Screw System VERTEX Nitinol Staple System NVa, NVp, NVt Intervertebral Body Fusion Device Focus Impact nvc

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2022-01-24
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2017-02-15
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2020-11-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-11-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-11-03
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2018-01-16
HXG	Tamp	Orthopedic	Class 1	888.4540	2015-11-13
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2025-04-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-04-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-11-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-06-23
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-24
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-11-18
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-11-18
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2022-05-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-05-06
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-05-06
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2017-02-15
HWW	Countersink	Orthopedic	Class 1	888.4540	2019-07-16
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-01-27
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2021-01-27
GFC	Driver, Surgical, Pin	General, Plastic Surgery	Class 1	878.4820	2017-02-15
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2019-05-10
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2019-06-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-06-12
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-07-12
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2019-05-10
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2019-03-26
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2018-07-18
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2025-04-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-04-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-04-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-24
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2017-02-15
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2023-06-01
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-06-01
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2025-04-17
HXW	Bender	Orthopedic	Class 1	888.4540	2017-02-15
HWJ	Awl	Orthopedic	Class 1	888.4540	2019-04-03
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-01-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-05-22
PLF	Bone Wedge	Orthopedic	Class 2	888.3030	2025-05-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-05-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-02-15
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-06-12
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2021-05-07
HXB	Probe	Orthopedic	Class 1	888.4540	2019-04-03
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2025-08-19
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2015-01-06

Official Correspondent

Anika Joseph-Smith

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Nvision Biomedical Technologies, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K193295	Parcus Medical, LLC	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	2020-01-23
K193606	Conmed Corporation	Y-Knot OneStep Anchor	2020-01-22
K984200	R. Thomas Grotz, M.D., Inc.	STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE	1999-01-21
K171060	Riverpoint Medical	OrthoButton AL	2017-06-02
K231867	Paragon 28, Inc.	Grappler Suture Anchor System	2023-08-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011301313. Last updated year: 2026. Please use registration number 3011301313 when referencing this establishment in official correspondence.