510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Nvision Biomedical Technologies, Inc

San Antonio, TX, US

NVISION BIOMEDICAL TECHNOLOGIES, INC appears in FDA device records in San Antonio, TX. FDA records list 38 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
38
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 38 510(k) clearances for Nvision Biomedical Technologies, Inc between 2014 and 2026. The busiest year on record is 2020, with 7. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Nvision Biomedical Technologies, Inc, by decision year
YearClearances
20142
20162
20172
20182
20194
20207
20213
20223
20232
20244
20255
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253718enHAnce PEEK Bunion SystemHRSSubstantially Equivalent
K260291Vortex5 Tailor's Bunion Correction SystemHRSSubstantially Equivalent
K253423ToeJack MIS Bunion SystemHRSSubstantially Equivalent
K252657Impact PEEK Union Nail SystemHTYSubstantially Equivalent
K250646Impact PEEK Union Nail SystemHTYSubstantially Equivalent
K250613SnapHammer Hammertoe Correction SystemHWCSubstantially Equivalent
K242896Caliber Intramedullary Fixation SystemHWCSubstantially Equivalent
K243231Trigon PEEK HA WedgesPLFSubstantially Equivalent
K2402503D Printed PEEK Interbody SystemMAXSubstantially Equivalent
K231453SnapHammer Hammertoe Correction SystemHWCSubstantially Equivalent
K234116Trigon Trigon HA Stand-Alone Wedge Fixation SystemPLFSubstantially Equivalent
K230853EARP Nerve Cuff ElectrodeETNSubstantially Equivalent
K222015Integral Titanium Cervical InterbodyODPSubstantially Equivalent
K223226Trigon™ HA Stand-Alone Wedge Fixation SystemPLFSubstantially Equivalent
K212477EARP Interbody SystemMAXSubstantially Equivalent
K220197Trigon HA Wedge Fixation SystemPLFSubstantially Equivalent
K211650The Radian MIS Bunion SystemHRSSubstantially Equivalent
K213421Vector® Hammertoe Correction SystemHWCSubstantially Equivalent
K210424Quantum Anterior Cervical PlateKWQSubstantially Equivalent
K203445Trigon HA Stand-Alone Wedge Fixation SystemPLFSubstantially Equivalent
K202657Javelin Tailor's Bunion Fixation SystemHRSSubstantially Equivalent
K200428Multi-Drive Interference Screw SystemMBISubstantially Equivalent
K201850Vector Hammertoe Correction SystemHWCSubstantially Equivalent
K200914Healix Compression Screw SystemHWCSubstantially Equivalent
K193414Trigon HA Stand-Alone Wedge Fixation SystemPLFSubstantially Equivalent
K193645nva, nvp, and nvtMAXSubstantially Equivalent
K192645Trigon™ Ti Stand-Alone Wedge Fixation SystemPLFSubstantially Equivalent
K182943VERTEX Nitinol Staple SystemJDRSubstantially Equivalent
K190380nvcODPSubstantially Equivalent
K183055Vector Hammertoe Correction SystemHWCSubstantially Equivalent
K182949Healix™ Compression Screw SystemHWCSubstantially Equivalent
K180458FOCUS Pedicle Screw SystemNKBSubstantially Equivalent
K173091Boundary Anterior Lumbar Buttress PlateKWQSubstantially Equivalent
K170074nvcODPSubstantially Equivalent
K162426nva, nvp, and nvtMAXSubstantially Equivalent
K161524Tangis Anterior Cervical PlateKWQSubstantially Equivalent
K142328nvcODPSubstantially Equivalent
K142594nva, nvp, nvtMAXSubstantially Equivalent

Registered establishments

FDA registered establishments for Nvision Biomedical Technologies, Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30113013133011301313NVISION BIOMEDICAL TECHNOLOGIES, INC12449 Silicon Dr, San Antonio, TX 78249 US2026and 19 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain