Catalog Number

2100T-2000

Brand Name

Alamo P, Alamo T

Version/Model Number

2100T-2000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K140303

Product Code

HWM

Product Code Name

OSTEOTOME

Public Device Record Key

3203ae30-6339-44ac-b7ba-9da09a23fbc5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-