FDA.reportPublic FDA data

NA

Primary DI
00848486003166
Brand
NA
Company
MAKO SURGICAL CORP.
Model
160336
Catalog number
160336
Device description
HIP PROBE
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
K121064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121064000MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMMako Surgical Corporation2012-06-06OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848486003166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848486003166008484860031668484860031660848486003166

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic surgery system probe, reusableA long, slender, rod-like device made of metal, used during image guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip to that of a targeted tissue of interest within a patient so that this area of tissue is clearly pinpointed with respect to diagnostic images stored in the stereotactic surgery system. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
00848486002534VIZADISC1071301071302016-09-24
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

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00840606187541OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
04056481147112RT ElementsBrainlab SEOLO2026-10-22
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