NVISION BIOMEDICAL TECHNOLOGIES, INC

Matched from indexed company URL: Nvision Biomedical Technologies, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30113013133011301313NVISION BIOMEDICAL TECHNOLOGIES, INC1Y2026-01-0112449 Silicon Dr San Antonio TX US 78249

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00814008029723FOCUS - Rod, MIS, Lordotic 5.5X120mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.210-545-3713Diana@nvisionbiomed.com
00814008029730FOCUS - Rod, MIS, Lordotic 5.5X130mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.210-545-3713Diana@nvisionbiomed.com
00814008029747FOCUS - Rod Template. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.210-545-3713diana@nvisionbiomed.com
00814008029754FOCUS - Cross Connector Screw Driver. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.210-545-3713diana@nvisionbiomed.com
00814008029761Watershed Idea Foundry - Decoder Ring - Sample Product, do not implant.210-545-3713diana@nvisionbiomed.com
00814008029808Boundary - Instrument, Lumbar Buttress Plate Ratchet Sport Grip AO Handle. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.210-545-3713diana@nvisionbiomed.com
00814008029815FOCUS - Small Ratcheting T-Handle. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.210-545-3713diana@nvisionbiomed.com
00814008029822FOCUS - Tower Dis-Engage Instrument. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.210-545-3713diana@nvisionbiomed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1783361043326744K253423ToeJack MIS Bunion SystemHRS2025-11-18
1783362009141418K250646Impact PEEK Union Nail SystemHTY2025-06-11
1783361922713739K243231Trigon PEEK HA WedgesPLF2024-11-08
1783361687571204K242896Caliber Intramedullary Fixation SystemHWC2025-02-05
1783361612753645K2402503D Printed PEEK Interbody SystemMAX2024-09-17
1783361678059981K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemPLF2024-01-26
1783361858342312K231453SnapHammer Hammertoe Correction SystemHWC2024-02-16
1783361577725291K223226Trigon™ HA Stand-Alone Wedge Fixation SystemPLF2022-12-01
1783361467646533K222015Integral Titanium Cervical InterbodyODP2023-07-05
1783361649362954K220197Trigon HA Wedge Fixation SystemPLF2022-02-23
1783361176923325K213421Vector® Hammertoe Correction SystemHWC2021-11-19
1783361830845334K211650The Radian MIS Bunion SystemHRS2021-11-24
1783361659004310K210424Quantum Anterior Cervical PlateKWQ2021-10-22
1783361442513658K202657Javelin Tailor's Bunion Fixation SystemHRS2020-12-14
1783361289695785K201850Vector Hammertoe Correction SystemHWC2020-08-04
1783361180951484K200914Healix Compression Screw SystemHWC2020-05-05
1783361827564091K200428Multi-Drive Interference Screw SystemMBI2020-11-10
1783361741246327K193645nva, nvp, and nvtMAX2020-01-13
1783361974594616K193414Trigon HA Stand-Alone Wedge Fixation SystemPLF2020-02-25
1783361559406247K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemPLF2019-12-23
1783362028435702K190380nvcODP2019-03-21
1783361525864231K183055Vector Hammertoe Correction SystemHWC2019-02-19
1783361188753095K182949Healix™ Compression Screw SystemHWC2018-12-04
1783361268147912K182943VERTEX Nitinol Staple SystemJDR2019-04-04
1783361004295049K180458FOCUS Pedicle Screw SystemNKB2018-04-17
1783361691842512K173091Boundary Anterior Lumbar Buttress PlateKWQ2017-12-06
1783361234010720K170074nvcODP2017-01-24
1783361743004811K162426nva, nvp, and nvtMAX2016-09-29
1783361051650944K161524Tangis Anterior Cervical PlateKWQ2016-09-02
1783361926510214K142594nva, nvp, nvtMAX2014-11-28
1783361584091262K142328nvcODP2014-12-23
1783361114991854
1783361142481306
1783361176835741
1783361215086719
1783361256140705
1783361286329936
1783361306095919
1783361319402742
1783361532001481
1783361560314429
1783361584893023
1783361665689343
1783361745628825
1783361932111467
1783361992589691
1783362019553385
1783362035958244
1783362063174435

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HWC72025-02-05
PLF62024-11-08
MAX42024-09-17
ODP42023-07-05
HRS32025-11-18
KWQ32021-10-22
HTY12025-06-11
MBI12020-11-10
JDR12019-04-04
NKB12018-04-17

PMN#

GUDID#

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