FDA.reportPublic FDA data

STar™ Drive XL Frame Adapter

Primary DI
00873263002049
Brand
STar™ Drive XL Frame Adapter
Company
FHC, INC.
Model
70-FA-LX-XL-00228
Catalog number
70-FA-LX-XL
Device description
XL STar(TM) Leksell Stereotactic System(R) Adapter
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
K121950000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121950000MICROTARGETING XL STAR DRIVE SYSTEMFHC, Inc.2012-07-26HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00873263002049Direct MarkingGS10
00873263002285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00873263002049008732630020498732630020490873263002049
00873263002285008732630022858732630022850873263002285

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical micro targeting driveA calibrated guide mechanism used by a surgeon to manually operate a Z-axis positioner which allows extremely accurate placement of a single or multiple microelectrodes, stimulation electrodes, probes, instruments, or implantable devices, along a chosen track during neurosurgery on the brain. It is intended to be used with a neurosurgical stereotactic system. It typically consists of a metal, graduated frame along which an instrument holder traverses (e.g., approximately 50 mm) by adjustment of a graduated knob that revolves a fine pitched lead screw (e.g., one revolution of the knob will advance the drive by 1 mm). Some types can have an electrical motor attached for motorized drive.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity095 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)326-2905fhcinc@fh-co.com

Regulatory Flags#

DUNS number
108179458
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00873263007785microTargeting™ Insertion Tube66-IT(IT2)-0077866-IT(IT2)2026-05-08
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00873263003046WayPoint™ Surgical Kit66-WP-SKS-0030466-WP-SKS2016-09-17
00873263003190WayPoint™ Implant Kit66-WP-IKS-0031966-WP-IKS2016-09-17
00873263009604microTargeting™ Measurement Probe66-MO-31-0096066-MO-312026-03-16
00873263009468microTargeting™ PlatformMP-KIT-P-VO-00946MP-KIT-P-VO2026-03-16
00873263009475microTargeting™ Measurement Probe66-MO-31-0096066-MO-312026-03-16
10873263009625microTargeting™ ElectrodeMTDWLN(BP)(BP11)-00962MTDWLN(BP)(BP11)2026-03-12
00873263009611microTargeting™ ElectrodeMTDWLP(BP)(BP11)-00961MTDWLP(BP)(BP11)2026-03-12
10873263009618microTargeting™ ElectrodeMTDWLP(BP)(BP11)-00961MTDWLP(BP)(BP11)2026-03-12
00873263009628microTargeting™ ElectrodeMTDWLN(BP)(BP11)-00962MTDWLN(BP)(BP11)2026-03-12
00873263002254STar™ Drive XL Frame Adapter70-FA-RD-XL-0022570-FA-RD-XL2016-09-17
00873263002285STar™ Drive XL Frame Adapter70-FA-LX-XL-0022870-FA-LX-XL2016-09-17
00873263002322STar™ Drive Frame Adapter70-FA-LX-0023270-FA-LX2016-09-17
00873263002360microTargeting™ STar™ Array Insertion Tube Extractor70-CN-ET-0023670-CN-ET2016-09-17
00873263006047WayPoint™ Entry Offset Mounting Hub66-MP-EH-0060466-MP-EH2018-04-01
00873263006184STar™ Drive Frame Adapter70-FA-GP-0061870-FA-GP2017-08-29
00873263008546STar™ Drive Frame Adapter70-FA-LX-NN-0085470-FA-LX-NN2022-09-26

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Primary DI, Brand, Company table
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07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
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