Catalog Number

-

Brand Name

POROUS HYDROXYLAPATITE GRANULES, 3CC

Version/Model Number

911100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 01, 2017

Issuing Agency

In GS1

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

K863237

Product Code

LYC

Product Code Name

Bone grafting material, synthetic

Public Device Record Key

43b7a7b7-5526-4cc4-bcf8-209c3825d73d

Public Version Date

October 06, 2022

Public Version Number

4

DI Record Publish Date

May 11, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-