FDA.reportPublic FDA data

ACCUNAV®

Primary DI
00650551046479
Brand
ACCUNAV®
Company
PMT CORPORATION
Model
2103-113-30
Catalog number
2103-113-30
Device description
ANCHOR BOLT FOR ACCUNAV DEPTH ELECTRODE, FOR 3.2MM DRILL
Published
2016-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
00650551046479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00650551046479006505510464796505510464790650551046479

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-626-5463intl@pmtcorp.com
800-626-5463info@pmtcorp.com

Regulatory Flags#

DUNS number
039576871
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00650551006077INTEGRA3611-230-2-ST2026-05-18
00650551006084INTEGRA3614-42-2-ST2026-05-18
00650551006091INTERCONNECTION CABLE2127-12-01-087-QDC2026-05-18
00650551006114CORTAC®2110-64-1692026-05-18
00650551006138DEPTHALON®2102-02-1912026-05-18
00650551006145INTERCONNECTION CABLE2127-16-04-Y92026-05-18
00650551006176INTEGRA3614-14-2-IR2026-05-18
00650551006220INTERCONNECTION CABLE2120-10-0102026-05-18
00650551006237INTEGRA3611-691-IR-ST2026-05-18
00650551006459INTERCONNECTION CABLE2120-16-01-0112026-05-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10381780252429CRW®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252436Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14
10381780252443Integra®INTEGRA LIFESCIENCES CORPORATIONHAW2017-04-14