FDA.reportPublic FDA data

MAKO

Primary DI
00848486030957
Brand
MAKO
Company
MAKO SURGICAL CORP.
Model
212252
Catalog number
212252
Device description
MAKO STRAIGHT REAMER HANDLE
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
K141989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141989000MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEMMako Surgical Corporation2014-11-13OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00848486030957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00848486030957008484860309578484860309570848486030957

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic reamer handleA hand-held surgical device that is attached to the proximal end of an orthopaedic reamer shaft to allow the operator to manually rotate the cutting device. It typically has a T-shaped design and is made of a high-grade stainless steel alloy; it is available in a variety of sizes. 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
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
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
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00840493422602RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422619RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422626RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422633RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422640RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422657RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422664RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422671RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422688RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422695RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422701RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422718RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422725RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422732RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422749RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422756RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422763RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422770RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422787RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422794RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422800RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422817RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422824RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422831RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422848RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422855RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422862RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422879RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05
00840493422886RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-05