FDA.reportPublic FDA data

ReBOSSIS

Primary DI
04573190050347
Brand
ReBOSSIS
Company
ORTHOREBIRTH CO.,LTD.
Model
0.4g
Catalog number
ORB-0304C
Device description
ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide co glycolide). The electrospinning process used in manufacturing ReBOSSIS results in a cotton-like physical form. Due to its physical form, ReBOSSIS is flexible and can easily fill defects in appropriate amounts.
Published
2017-09-11
Public version status
Update
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
K170620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170620000ReBOSSIS85Orthorebirth Co., Ltd.2017-06-23MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04573190050347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04573190050347045731900503474573190050347

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry place
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-426-2323dblake@orthorebirthusa.com

Regulatory Flags#

DUNS number
691435666
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04573190050613ZENBONE2.0gORB-0320C-Z2025-06-16
04573190050620ZENBONE1.0gORB-0310C-Z2025-06-16
04573190050637ZENBONE0.4gORB-0304C-Z2025-06-16
04573190050552BioCera Fibers QDS0.25gORB-0305D-KC2025-05-28
04573190050309ReBOSSIS0.2gORB-0302C2024-09-01
04573190050378ReBOSSIS2.0gORB-0320C2024-09-01
04573190050385ReBOSSIS1.0gORB-0310C2024-09-01
04573190050392ReBOSSIS0.4gORB-0304C2024-09-01
04573190050514BioCera Fibers2.0gORB-0320C-KC2024-03-25
04573190050521BioCera Fibers1.0gORB-0310C-KC2024-03-25
04573190050538BioCera Fibers0.4gORB-0304C-KC2024-03-25
04573190050545BioCera Fibers0.2gORB-0302C-KC2024-03-25
04573190050361ReBOSSIS QDS0.25gORB-0305D2019-11-01
04573190050316ReBOSSIS2.0gORB-0320C2017-09-11
04573190050323ReBOSSIS1.0gORB-0310C2017-09-11
04573190050330ReBOSSIS0.7gORB-0307C2017-09-11
04573190050354ReBOSSIS QDS0.5gORB-0305D2018-05-30
04573190050019ReBOSSIS2.0gORB-0120S2015-09-24
04573190050026ReBOSSIS1.0gORB-0110S2015-09-24
04573190050033ReBOSSIS0.7gORB-0107S2015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
07610221017829Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017836Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017843Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017850Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017867Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017874Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017881Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017898Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017904Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017911Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017928Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
03760191133723GlassBone GranulesNORAKERMQV2026-05-27
03760191133730GlassBone GranulesNORAKERMQV2026-05-27
03760191133747GlassBone GranulesNORAKERMQV2026-05-27
03760191133754GlassBone GranulesNORAKERMQV2026-05-27
03760191133761GlassBone GranulesNORAKERMQV2026-05-27
03760191133778GlassBone GranulesNORAKERMQV2026-05-27
03760191133785GlassBone GranulesNORAKERMQV2026-05-27
03760191134812AktiBone GranulesNORAKERMQV2026-05-27
03760191134829AktiBone GranulesNORAKERMQV2026-05-27
03760191134836AktiBone GranulesNORAKERMQV2026-05-27
03760191134843AktiBone GranulesNORAKERMQV2026-05-27
03760191134850AktiBone GranulesNORAKERMQV2026-05-27
03760191134867AktiBone GranulesNORAKERMQV2026-05-27
03760191134874AktiBone GranulesNORAKERMQV2026-05-27
03760191134881MectaBlast GranulesNORAKERMQV2026-05-27
03760191134898MectaBlast GranulesNORAKERMQV2026-05-27
03760191134904MectaBlast GranulesNORAKERMQV2026-05-27
03760191134911MectaBlast GranulesNORAKERMQV2026-05-27