XIPHOS ZFUZE - TLIF Spacer 27mm Long x 11mm Height - Difusion Technologies, Inc.

Duns Number:022051967

Device Description: TLIF Spacer 27mm Long x 11mm Height

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More Product Details

Catalog Number

ZF-300-2711

Brand Name

XIPHOS ZFUZE

Version/Model Number

ZF-300-2711

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

K190544

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Device Record Status

Public Device Record Key

5c69c153-ce77-4f7c-b7bb-1a283bb8f27b

Public Version Date

March 02, 2020

Public Version Number

1

DI Record Publish Date

February 21, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIFUSION TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 42