KIT DUALX LLIF 12-15MM x 0 DEG x 45MM - LLIF IMPLANT - 0° x 22MM IMPLANTSLordosis & - Amplify Surgical, Inc.

Duns Number:081021000

Device Description: LLIF IMPLANT - 0° x 22MM IMPLANTSLordosis & Heights: 12-15mm x 0° x 45mmCollapsed Width (m LLIF IMPLANT - 0° x 22MM IMPLANTSLordosis & Heights: 12-15mm x 0° x 45mmCollapsed Width (mm): 13.34Expanded Width (mm): 22Collapsed Height (mm): 12.5Expanded Height (mm): 15.5Collapsed Length (mm): 53.76Expanded Length (mm): 46.8LLIF SCREW - 45MM

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More Product Details

Catalog Number

-

Brand Name

KIT DUALX LLIF 12-15MM x 0 DEG x 45MM

Version/Model Number

12833005017

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

K181397

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Device Record Status

Public Device Record Key

4a68f640-bd7b-4444-8f40-35c86507f729

Public Version Date

May 21, 2021

Public Version Number

5

DI Record Publish Date

May 13, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AMPLIFY SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 277