ACCOLADE II - 127DEG 30mm NECK TRIAL - MAKO SURGICAL CORP.

Duns Number:175239677

Device Description: 127DEG 30mm NECK TRIAL

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More Product Details

Catalog Number

210433-2730

Brand Name

ACCOLADE II

Version/Model Number

210433-2730

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K141989,K170593

Product Code Details

Product Code

OLO

Product Code Name

Orthopedic stereotaxic instrument

Device Record Status

Public Device Record Key

6730273c-41b5-4351-bab6-64e12c775309

Public Version Date

June 07, 2022

Public Version Number

6

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAKO SURGICAL CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 75
2 A medical device with a moderate to high risk that requires special controls. 886