FDA.reportPublic FDA data

PLANNING STATION - USA

Primary DI
00889024714113
Brand
PLANNING STATION - USA
Company
MEDTECH
Model
ROSAS00503
Device description
Planning station for Rosa One 3.1.7.21
Published
2026-09-28
Public version status
New
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
K231103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231103000ROSA ONE Brain ApplicationMedtech S.A.S2023-07-20HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024714113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024714113008890247141138890247141130889024714113

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
00887868539978SEEG DRILL ADAPTOR 2.70MMROSAS000852025-06-24
03760244034625SEEG DRILL ADAPTOR Ø2.5MMROSAS000802022-02-18
03760244034632SEEG DRILL ADAPTOR Ø2.15MMROSAS000812022-02-18
03760244034649SEEG DRILL ADAPTOR Ø2.45MMROSAS000822022-02-18
03760244034656SEEG DRILL ADAPTOR Ø2.55MMROSAS000832022-02-18
03760244034663SEEG DRILL ADAPTOR Ø3.2MMROSAS000842022-02-18
03760244031914LEKSELL FRAME REGISTRATION PLATESROSAS005002020-10-20
03760244034069LEKSELL FRAME REGISTRATION PLATESROSAS005002020-10-20
03760244031815SEEG SST DRILL ADAPTOR Ø2.15MMROSAS000812019-07-26
03760244031822SEEG SST DRILL ADAPTOR Ø2.45MMROSAS000822019-07-26
03760244031839SEEG SST DRILL ADAPTOR Ø2.5MMROSAS000802019-07-26
03760244031846SEEG SST DRILL ADAPTOR Ø2.55MMROSAS000832019-07-26
03760244031860SEEG SST DRILL ADAPTOR Ø3.2MMROSAS000842019-07-26
03760244031877PEEK Instrument adaptor Ø1.80 mmROSAS000602019-07-26
03760244031884PEEK INSTRUMENT ADAPTOR Ø2MMROSAS000682019-07-26
03760244031891SEEG CANNULA SST ADP Ø 3,2mmROSAS000912019-07-27
03760244031907SEEG CANNULA SST ADP Ø 4mmROSAS000902019-07-27
03760244031969INSTRUMENT HOLDER (V3)ROSAS004982020-06-02
03760244032140POINTER PROBE (V3)ROSAS003152019-09-04
03760244032317INST RND PEEK ADP Ø2.1MMROSAS000712019-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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06974813832841NASinovation (Beijing) Medical Technology Co., LtdHAW2026-09-29
00889024713895ROSA ONE BRAIN APPLICATION (US)MEDTECHHAW2026-09-28
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