FDA.reportPublic FDA data

NA

Primary DI
07613327468311
Brand
NA
Company
MAKO SURGICAL CORP.
Model
700000357480
Catalog number
700000357480
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
07613327468311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327468311076133274683117613327468311

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

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
No natural rubber latex
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