FDA.reportPublic FDA data

PMT CORPORATION - STEREOTACTIC

Primary DI
00650551149446
Brand
PMT CORPORATION - STEREOTACTIC
Company
PMT CORPORATION
Model
2103-175
Device description
VERTEK STERILIZATION TRAY FOR SEEG 2.1MM DRILL BIT WITH STEREOTACTIC SYSTEM COMPONENTS
Published
2025-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K831329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K831329000PMT VAXIOM STEREOTACTIC SYS #FX001Progress Mankind Technology1983-06-15HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00650551149446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551149446006505511494466505511494460650551149446

GMDN Terms#

Term, Definition table
TermDefinition
Neurological stereotactic surgery systemAn assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Sterilization Methods#

Method table
Method
"[""Hydrogen Peroxide"", ""Moist Heat or Steam Sterilization""]"
Hydrogen Peroxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
039576871
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00650551006633CORTAC®2110-04-0832026-06-04
00650551006640CORTAC®2110-08-1442026-06-04
00650551006657CORTAC®2110-16-1362026-06-04
00650551006664CORTAC®2110-20-1172026-06-04
00650551006671CORTAC®2110-32-1432026-06-04
00650551006688CORTAC®2110-48-1122026-06-04
00650551006695CORTAC®2110-64-1702026-06-04
00650551006602PMT CORPORATION2127-16-01-088-QDC2026-06-01
00650551006619PMT CORPORATION2127-16-01-089-QDC2026-06-01
00650551006626PMT CORPORATION2127-16-01-090-QDC2026-06-01
00650551006596INTEGRA3610-638-2I-ST62026-05-27
00650551006572DEPTHALON®2102-06-005-NS2026-05-26
00650551006589DEPTHALON®2102-06-0052026-05-26
00650551005537DEPTHALON®2104-04-32-0012026-05-18
00650551005865MICROMAT®3105-M-B-122026-05-18
00650551005872MICROMAT®3105-M-Y-122026-05-18
00650551006022INTEGRA3610-76-ST2026-05-18
00650551006039INTEGRA3610-76-2-ST2026-05-18
00650551006046INTEGRA3611-690-2-ST2026-05-18
00650551006060INTEGRA3610-636-3-ST2026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000811129MedtronicMEDTRONIC NAVIGATION, INC.HAW2026-06-07
00860012056828Zeta Navigation SystemZeta Surgical Inc.HAW2026-06-02
08720892330826Ball Joint Guide Array (BJGA)-Navigation SetBayer Medical Care B.V.HAW2026-04-24
08720892330833Ball Joint Guide Array (BJGA)-Guide SetBayer Medical Care B.V.HAW2026-04-24
07340201501887Leksell Vantage Stereotactic SystemElekta Solutions ABHAW2025-03-31
10381780542278CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-28
10381780542285CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-28
10381780542292Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2024-06-03
G076A012354A1Localite TMS Navigator TSLOCALITE GmbHHAW2023-07-05
G076A012355A1Localite TMS Navigator TSLOCALITE GmbHHAW2023-07-05
07613327499711N/AStryker Leibinger GmbH & Co. KGHAW2023-03-23
07613327500516N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327500561N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327500578N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
07613327503265N/AStryker Leibinger GmbH & Co. KGHAW2022-07-22
10603295522850VELYSDEPUY (IRELAND)HAW2021-07-30
07613327413076n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
07613327413090n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
07613327413205n/aStryker Leibinger GmbH & Co. KGHAW2018-08-08
10603295493624SIGMADEPUY ORTHOPAEDICS, INC.HAW2018-04-19
10650551098277PMT CORPORATION - STEREOTACTICPMT CORPORATIONHAW2018-01-28
10381780167334CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252252CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252351Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252368Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252375CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252382Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252399Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252405CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252412CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14