FDA.reportPublic FDA data

PLANNING STATION-ROSA ONE- USA

Primary DI
03760244035127
Brand
PLANNING STATION-ROSA ONE- USA
Company
MEDTECH
Model
ROSAS00503
Published
2022-06-20
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
K200511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200511000ROSA ONE Brain applicationMedtech S.A2020-05-29HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760244035127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760244035127037602440351273760244035127

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose stereotactic surgery systemAn electrically-powered 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 a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.

Contacts#

Phone, Email table
PhoneEmail
1(800)348-2759product.experience@zimmerbiomet.com

Regulatory Flags#

DUNS number
264502977
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024713895ROSA ONE BRAIN APPLICATION (US)ROSAS002032026-09-28
00889024714113PLANNING STATION - USAROSAS005032026-09-28
00889024704213PLANNING STATION - USAROSAS005032026-02-23
00889024679559ALLEN WRENCH 8MMROSAS005362025-07-15
00889024663282PLANNING STATION - ROSA ONE - USAROSAS005032024-02-20
03760244031129Trnsnsl Endscp Ovoid Ø6.18mm HolderROSAS003182023-10-27
00887868585951ROSA ONE BRAIN APPLICATION (US)ROSAS002032023-10-30
03760244034793ROSA ONE SURGICAL ASSISTANT (US)ROSAS002032022-06-20
03760244034922PLANNING STATION-ROSA ONE- USAROSAS005032022-06-20
03760244034632SEEG DRILL ADAPTOR Ø2.15MMROSAS000812022-02-18
03760244032195Optical distance sensorROSAS003162021-06-15
03760244034304ROBOT ROSA ONE (USA)ROSAS002032021-05-31
03760244034403PLANNING STATION Rosa One -USAROSAS005032021-05-31
03760244030962CRW frame adaptorROSAS003212020-11-20
03760244032218TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 3,9 mmROSAS003172020-10-20
03760244032294TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 5,1 mmROSAS003202020-10-20
03760244034083TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 3,9 mmROSAS003172020-10-20
03760244034090TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 5,1 mmROSAS003202020-10-20
03760244031235MAYFIELD HEAD HOLDER ADAPTORROSAS003252016-10-09
03760244032119MAYFIELD HEAD HOLDER ADAPTORROSAS003252020-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07340201503829Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503836Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503843Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503850Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503867Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-20
07340201503812Leksell Neurosurgical InstrumentsElekta Solutions ABHAW2026-10-19
00889024713895ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2026-09-28
00889024714113PLANNING STATION - USAMEDTECHHAW2026-09-28
00889024704213PLANNING STATION - USAMEDTECHHAW2026-02-23
04056481146702Curve NavigationBrainlab SEHAW2025-10-13
00889024679559ALLEN WRENCH 8MMMEDTECHHAW2025-07-15
00887868539978SEEG DRILL ADAPTOR 2.70MMMEDTECHHAW2025-06-24
00889024663282PLANNING STATION - ROSA ONE - USAMEDTECHHAW2024-02-20
00887868585951ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2023-10-30
03760244031129Trnsnsl Endscp Ovoid Ø6.18mm HolderMEDTECHHAW2023-10-27
04056481144500Curve Navigation 17700Brainlab SEHAW2023-05-22
03760244034793ROSA ONE SURGICAL ASSISTANT (US)MEDTECHHAW2022-06-20
03760244034922PLANNING STATION-ROSA ONE- USAMEDTECHHAW2022-06-20
03760244034625SEEG DRILL ADAPTOR Ø2.5MMMEDTECHHAW2022-02-18
03760244034632SEEG DRILL ADAPTOR Ø2.15MMMEDTECHHAW2022-02-18
03760244034649SEEG DRILL ADAPTOR Ø2.45MMMEDTECHHAW2022-02-18
03760244034656SEEG DRILL ADAPTOR Ø2.55MMMEDTECHHAW2022-02-18
03760244034663SEEG DRILL ADAPTOR Ø3.2MMMEDTECHHAW2022-02-18
03760244032195Optical distance sensorMEDTECHHAW2021-06-15
03760244034304ROBOT ROSA ONE (USA)MEDTECHHAW2021-05-31
03760244034403PLANNING STATION Rosa One -USAMEDTECHHAW2021-05-31
04056481143503Kick 2 Navigation StationBrainlab SEHAW2021-05-31
03760244030962CRW frame adaptorMEDTECHHAW2020-11-20
03760244031914LEKSELL FRAME REGISTRATION PLATESMEDTECHHAW2020-10-20
03760244032218TRANSNASAL ENDOSCOPY INTRUMENT HOLDER Ø 3,9 mmMEDTECHHAW2020-10-20