FDA.reportPublic FDA data

NA

Primary DI
07613327624304
Brand
NA
Company
MAKO SURGICAL CORP.
Model
229999
Catalog number
229999
Device description
Robotic Arm
Published
2024-09-18
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327624304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327624304076133276243047613327624304

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

Regulatory Flags#

DUNS number
175239677
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327623260Mako7000026060217000026060212026-05-29
07613327594829Common Shoulder Driver1906601906602026-05-21
07613327595543Mako2906512906512026-05-21
07613327579888N/A7000015775787000015775782024-08-07
07613327595505Mako Glenoid RetractorSmall1906652026-01-08
07613327625868INSTRUMENT7000021128907000021128902024-10-04
07613327395280NA2199992199992020-12-15
00848486021702RIO2038662038662016-09-24
00848486022211NA2071102071102016-09-24
00848486023249NA2099272099272016-09-24
00848486030407NA2099992099992016-09-24
07613327627725MakoShoulder 1.0+TKA 2.0.1+TKA 1.0.3+THA 4.17000028873152026-03-10
07613327683653Shoulder 1.5 Installation Disk7000043787467000043787462026-03-03
00848486000349RESTORIS180320-2180320-22015-09-24
00848486000356RESTORIS180320-1180320-12015-09-24
00848486000370RESTORIS180320-4180320-42015-09-24
00848486000387RESTORIS180320-5180320-52015-09-24
00848486000394RESTORIS180320-6180320-62015-09-24
00848486000400RESTORIS1804021804022015-09-24
00848486000417RESTORIS1804031804032015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423319RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423326RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423333RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423340RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423357RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423364RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423371RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423388RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423395RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423401RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423418RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423425RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423456RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08