Bicera® Resorbable Bone Substitute

Primary DI
04719875721915
Brand
Bicera® Resorbable Bone Substitute
Company
WILTROM CO., LTD.
Model
BC-B01(5x5x20mm,2c.c.)
Device description
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.
Published
2020-12-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172237000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172237000Bicera Resorbable Bone SubstituteWiltrom Corporation Limited2018-02-02MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719875721915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719875721915047198757219154719875721915

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature23 Degrees Celsius27 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+88636107168yichun@wiltrom.com.tw

Regulatory Flags#

DUNS number
656680902
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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04719875729874Wiltrom Spinal Fixation System43587565 Polyaxial Reduction Pedicle Screw, Cannul2023-10-11
04719875729881Wiltrom Spinal Fixation System43587570 Polyaxial Reduction Pedicle Screw, Cannul2023-10-11
04719873025299Wiltrom Spinal Fixation System43577030 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
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04719873025350Wiltrom Spinal Fixation System43577060 Polyaxial Reduction Pedicle Screw ø=7.0 L2022-11-30
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