Catalog Number

10-1335M

Brand Name

SpF XL IIb Implantable Spinal Fusion Stimulator

Version/Model Number

10-1335M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

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

P850035

Product Code

LOE

Product Code Name

Stimulator, Invasive Bone Growth

Public Device Record Key

66b0493a-bb74-47fb-866e-0a8855ba558f

Public Version Date

March 10, 2022

Public Version Number

4

DI Record Publish Date

September 19, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-