SureMAX - Cervical Wedge Distractor, 7° Lordotic Large - ADDITIVE IMPLANTS, LLC

Duns Number:057002266

Device Description: Cervical Wedge Distractor, 7° Lordotic Large (15mm x 18mm) x 10.5mm

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More Product Details

Catalog Number

-

Brand Name

SureMAX

Version/Model Number

1

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K182477

Product Code Details

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

aa06ee1a-3dea-4af0-be1c-c2873c71c53e

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 21, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADDITIVE IMPLANTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 212
2 A medical device with a moderate to high risk that requires special controls. 254