ENCLAVE™ ANTERIOR SPINAL SYSTEM - BIOMET SPINE LLC

Duns Number:018577570

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More Product Details

Catalog Number

14-530499

Brand Name

ENCLAVE™ ANTERIOR SPINAL SYSTEM

Version/Model Number

14-530499

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

-

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Device Record Status

Public Device Record Key

c803efcd-85b8-4b10-8a88-78261e424f20

Public Version Date

March 10, 2022

Public Version Number

2

DI Record Publish Date

April 07, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOMET SPINE LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 491
2 A medical device with a moderate to high risk that requires special controls. 31582
U Unclassified 546