FDA.reportPublic FDA data

NA

Primary DI
00848486002985
Brand
NA
Company
MAKO SURGICAL CORP.
Model
116240
Catalog number
116240
Device description
CORTICAL SCREW
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K121064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112507000RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEMMako Surgical Corporation2012-03-01OLO
K121064000MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEMMako Surgical Corporation2012-06-06OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848486002985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848486002985008484860029858484860029850848486002985

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, implantableA sterile device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically formed as a wire, needle, bead, stent-like tube or washer, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
175239677
Device count
1
Lot or batch
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493422398RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422404RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422411RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422428RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422435RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422442RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422459RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422466RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422473RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422480RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422497RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422503RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422510RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422527RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422534RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422541RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422558RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422565RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422572RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422589RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-03
00840493422268RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422275RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422282RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422299RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422305RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422312RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422329RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422336RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422343RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02
00840493422350RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-02