Elite Expandable Interbody Fusion Device - 12mm Elite Expandable - SPINEOLOGY INC.

Duns Number:033014361

Device Description: 12mm Elite Expandable

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More Product Details

Catalog Number

541-0504

Brand Name

Elite Expandable Interbody Fusion Device

Version/Model Number

10-10-74-23

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Unsafe

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

K162879

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Device Record Status

Public Device Record Key

1a5c6614-91cb-4f1c-88b8-ca98358d5966

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 03, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINEOLOGY INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1132
U Unclassified 13