FDA.reportPublic FDA data

Scapular Clamp

Primary DI
07613327595482
Brand
Scapular Clamp
Company
MAKO SURGICAL CORP.
Model
190661
Catalog number
190661
Published
2026-01-30
Public version status
New
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
07613327595482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327595482076133275954827613327595482

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioning sensorA device designed to detect and respond to movement and transmits a signal proportional to the degree of motion. A parent device will receive these signals and show the position of the sensor and the object to which it is attached and make the necessary display/control adjustments for the object being monitored. It may be permanently attached to an electrical cable that relays energy to the sensor and signals back to the parent device. It may be affixed to the leg of a patient during computer assisted surgery (CAS) for implantation of a hip prosthesis to assist in the correct positioning of the implant or as a component of an electromagnetic device tracking 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
No natural rubber latex
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
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424989RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493424996RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13
00840493425009RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-07-13