Catalog Number

1110-01-5540

Brand Name

Apelo® / Apelo® MIS

Version/Model Number

1110-01-5540

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

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

K110842

Product Code

NKB

Product Code Name

Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

Public Device Record Key

bf15403d-a323-466b-96dd-76a255ce880d

Public Version Date

August 26, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-