SureMAX-X - SureMAX-X Cervical Spacer, 10° Midlordotic Large - ADDITIVE IMPLANTS, LLC

Duns Number:057002266

Device Description: SureMAX-X Cervical Spacer, 10° Midlordotic Large (15mm x 18mm) x 9mm

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More Product Details

Catalog Number

1802-10151809

Brand Name

SureMAX-X

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K193359

Product Code Details

Product Code

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

6b932f45-66be-49bc-a7fa-de272ad0a336

Public Version Date

March 12, 2020

Public Version Number

1

DI Record Publish Date

March 04, 2020

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