Kyocera Medical Technologies, Inc. - Reduction Cannulated Polyaxial Screw 6.5mm - KYOCERA MEDICAL TECHNOLOGIES, INC.

Duns Number:116995646

Device Description: Reduction Cannulated Polyaxial Screw 6.5mm diameter 75mm length for use with a 5.5 Rod

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More Product Details

Catalog Number

1116-653-075

Brand Name

Kyocera Medical Technologies, Inc.

Version/Model Number

S 100

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

Yes

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

K111940

Product Code Details

Product Code

MNH

Product Code Name

Orthosis, Spondylolisthesis Spinal Fixation

Device Record Status

Public Device Record Key

dfc0bd1f-f5f1-4363-9599-f3e132e0ba9a

Public Version Date

July 18, 2019

Public Version Number

3

DI Record Publish Date

January 16, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KYOCERA MEDICAL TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2246
2 A medical device with a moderate to high risk that requires special controls. 3237