FDA.reportPublic FDA data

NA

Primary DI
07613327468298
Brand
NA
Company
MAKO SURGICAL CORP.
Model
700000380980
Catalog number
700000380980
Published
2020-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K193128000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193128000Mako Total Hip ApplicationMako Surgical Corp.2020-02-02OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327468298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327468298076133274682987613327468298

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(954)628-0802MakoCustomerService@stryker.com

Regulatory Flags#

DUNS number
175239677
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00848486001414VIZADISC1071201071202016-09-24
07613327626971Mako1.01906872024-11-15
00848486001346NA1116501116502016-09-24
00848486001353NA1116511116512016-09-24
00848486001360NA1116521116522016-09-24
00848486002978NA1162301162302016-09-24
00848486002985NA1162401162402016-09-24
00848486017316NA1116531116532016-09-24
00848486017323NA1116551116552016-09-24
00848486029487NA1116441116442016-09-24
00848486029494NA1116451116452016-09-24
07613327579840N/A7000015775847000015775842025-09-08
07613327579888N/A7000015775787000015775782024-08-07
07613327630602Mako7000029506277000029506272026-08-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810076335322MomentumUlrich Medical Usa, Inc.OLO2026-09-25
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOLO2026-09-25
00810131884062TiLink-L Rescue DilatorSurgentec, LLCOLO2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOLO2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOLO2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25
07613327460667Navigation EnabledStryker CorporationOLO2019-10-16
07613327460674Navigation EnabledStryker CorporationOLO2019-10-16
07613327460681Navigation EnabledStryker CorporationOLO2019-10-16
07613327460698Navigation EnabledStryker CorporationOLO2019-10-16
07613327460704Navigation EnabledStryker CorporationOLO2019-10-16
07613327460711Navigation EnabledStryker CorporationOLO2019-10-16
07613327460728Navigation EnabledStryker CorporationOLO2019-10-16
07613327460735Navigation EnabledStryker CorporationOLO2019-10-16
07613327460742Navigation EnabledStryker CorporationOLO2019-10-16
07613327460759Navigation EnabledStryker CorporationOLO2019-10-16
07613327460766Navigation EnabledStryker CorporationOLO2019-10-16
07613327460773Navigation EnabledStryker CorporationOLO2019-10-16
07613327460780Navigation EnabledStryker CorporationOLO2019-10-16
07613327460797Navigation EnabledStryker CorporationOLO2019-10-16
07613327460810Navigation EnabledStryker CorporationOLO2019-10-16
07613327460827Navigation EnabledStryker CorporationOLO2019-10-16
07613327460834Navigation EnabledStryker CorporationOLO2019-10-16
07613327460841Navigation EnabledStryker CorporationOLO2019-10-16
07613327460858Navigation EnabledStryker CorporationOLO2019-10-16
07613327460865Navigation EnabledStryker CorporationOLO2019-10-16
07613327460872Navigation EnabledStryker CorporationOLO2019-10-16
07613327460889Navigation EnabledStryker CorporationOLO2019-10-16
07613327460896Navigation EnabledStryker CorporationOLO2019-10-16