FDA.reportPublic FDA data

NA

Primary DI
00848486022211
Brand
NA
Company
MAKO SURGICAL CORP.
Model
207110
Catalog number
207110
Device description
Guidance Module
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
00848486022211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848486022211008484860222118484860222110848486022211

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical navigation systemAn assembly of electromechanical devices used during orthopaedic computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It is computer-based and typically consists of, e.g., an operator's console and a video camera used to track the instrumentation. The input to the computer is usually by means of an existing CT or MRI scan that is used as a template. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
175239677
Device count
1
Serial number
true
Sterilization required before use
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
00840493426426RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426433RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426440RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426457RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426464RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426471RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426488RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426495RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426501RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426518RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426525RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426532RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426549RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426556RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426563RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426570RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426587RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426594RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426600RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426617RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426624RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00840493426631RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-08-18
00193982621940DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
00193982622039DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
00193982622091DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
00193982622114DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
00193982622138DURAPROGLOBUS MEDICAL, INC.OLO2026-08-14
00763000995195Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-08-14
00763000995218Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-08-14
00763000995232Stealth AXiSMEDTRONIC NAVIGATION, INC.OLO2026-08-14