FDA.reportPublic FDA data

Mako Glenoid Retractor

Primary DI
07613327595505
Brand
Mako Glenoid Retractor
Company
MAKO SURGICAL CORP.
Model
Small
Catalog number
190665
Published
2026-01-08
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
07613327595505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327595505076133275955057613327595505

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

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
07613327623260Mako7000026060217000026060212026-05-29
07613327594829Common Shoulder Driver1906601906602026-05-21
07613327595543Mako2906512906512026-05-21
07613327579888N/A7000015775787000015775782024-08-07
07613327625868INSTRUMENT7000021128907000021128902024-10-04
07613327624304NA2299992299992024-09-18
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

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Primary DI, Brand, Company table
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00840493423432RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423449RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
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