FDA.reportPublic FDA data

N/A

Primary DI
07613327579888
Brand
N/A
Company
MAKO SURGICAL CORP.
Model
700001577578
Catalog number
700001577578
Device description
Tracking Instrument Battery
Published
2024-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327579888PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327579888076133275798887613327579888

GMDN Terms#

Term, Definition table
TermDefinition
Optical surgical navigation device tracking systemA mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., endoscopic, ultrasound (US)] during computer assisted surgery (CAS). It consists of a workstation with controls/display, a position/movement tracking camera, adaptors, and sensors/spatial markers designed to be attached to the patient and instruments. It is used for multiple surgical procedures (e.g., craniotomy, tumour resection) in various fields [e.g., ear/nose/throat (ENT), neurosurgical, or craniomaxillofacial (CMF) surgery].

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity25 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00FRAGILE
Special Storage Condition, Specify00KEEP AWAY FROM HEAT
Special Storage Condition, Specify00KEEP DRY
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature4 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)253-3210INST.STRYKER.CS@STRYKER.COM

Regulatory Flags#

DUNS number
175239677
Device count
1
Lot or batch
true
Expiration date on label
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