Bicera® Resorbable Bone Substitute - Bicera® Resorbable Bone Substitute is a - WILTROM CO., LTD.

Duns Number:656680902

Device Description: Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of Bicera® Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60%hydroxyapatite (HAP) and 40% beta-tricalcium (ß-TCP). Bicera® Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera® Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera® Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis) as a bone void filler. This product provides a bone void filler that resorbs and is replaced by bone during the healing process.

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More Product Details

Catalog Number

-

Brand Name

Bicera® Resorbable Bone Substitute

Version/Model Number

BC-B07(5x5x20mm,7c.c.)

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

K172237

Product Code Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

50631cff-bc19-4d5b-badb-24e723a1b7d3

Public Version Date

January 06, 2021

Public Version Number

1

DI Record Publish Date

December 29, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WILTROM CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 77