FDA.reportPublic FDA data

RIO

Primary DI
00848486015879
Brand
RIO
Company
MAKO SURGICAL CORP.
Model
207138
Catalog number
207138
Device description
RIO¿ Foot Switch
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112507000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112507000RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEMMako Surgical Corporation2012-03-01OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848486015879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848486015879008484860158798484860158790848486015879

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
175239677
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848486016401Mako180732-2180732-22015-11-04
00848486016418Mako180732-3180732-32015-11-04
00848486016432Mako180732-5180732-52015-11-04
00848486016449Mako180733-1180733-12015-11-04
00848486016456Mako180733-2180733-22015-11-04
00848486016463Mako180733-3180733-32015-11-04
00848486016487Mako180733-5180733-52015-11-04
00848486016494Mako180734-1180734-12015-11-04
00848486016500Mako180734-2180734-22015-11-04
00848486016517Mako180734-3180734-32015-11-04
00848486016531Mako180734-5180734-52015-11-04
00848486016548Mako180735-1180735-12015-11-04
00848486016555Mako180735-2180735-22015-11-04
00848486016562Mako180735-3180735-32015-11-04
00848486016586Mako180735-5180735-52015-11-04
00848486016593Mako180736-1180736-12015-11-04
00848486016609Mako180736-2180736-22015-11-04
00848486016616Mako180736-3180736-32015-11-04
00848486016630Mako180736-5180736-52015-11-04
00848486016647Mako180737-1180737-12015-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901035PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901615PrimusSPINAL ELEMENTS, INC.OLO2026-07-21
00840466901622PrimusSPINAL ELEMENTS, INC.OLO2026-07-21