FDA.reportPublic FDA data

BioSphere Flex SP

Primary DI
M958BSF00150
Brand
BioSphere Flex SP
Company
SYNERGY BIOMEDICAL, LLC
Model
Large
Catalog number
BSF-00150
Published
2020-01-31
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
K173424000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173424000BioSphere FlexSynergy Biomedical2018-09-12MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M958BSF00150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, synthetic, non-antimicrobialA bioabsorbable device made of synthetic material intended to be implanted into the body to provide osteoconductive bone-tissue scaffolds, and sometimes osteovascularization, to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis); it does not include an antimicrobial agent(s). It may be made of ceramics (e.g., tricalcium phosphate or hydroxyapatite), bioactive glasses/minerals/metals (e.g., strontium), or bioabsorbable polymers. It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts and is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable/fluid materials.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume15Milliliter

Contacts#

Phone, Email table
PhoneEmail
484-902-8141info@synergybiomedical.com

Regulatory Flags#

DUNS number
078270195
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M958BMS250KT0BioSphere MIS KitBMS-250KT2024-12-09
M958BMS250RC0BioSphere MIS Replacement CannulaBMS-250RC2024-12-09
M958BSF000300BioSphere Flex SP Extremities, SmallBSF-000302021-06-01
M958BSF000400BioSphere Flex SP Extremities, MediumBSF-000402021-06-01
M958BSF250500BioSphere Flex, MediumBSF-250502021-06-01
M958BSF251000BioSphere Flex, LargeBSF-251002021-06-01
M958BMS050KT0BioSphere MISKitBMS-050KT2018-02-12
M958BMS050RC0BioSphere MISReplacement CannulaBMS-050RC2018-02-12
M958BPY0010BioSphere Putty1ccBPY-0012017-02-12
M958BPY0010RBioSphere Putty1ccBPY-0012017-02-12
M958BPY0250BioSphere Putty2.5ccBPY-0252017-02-12
M958BPY0250XBioSphere Putty2.5ccBPY-0252017-02-12
M958BPY0500BioSphere Putty5ccBPY-0502017-02-12
M958BPY0500VBioSphere Putty5ccBPY-0502017-02-12
M958BPY1000BioSphere Putty10ccBPY-1002017-02-12
M958BPY1000RBioSphere Putty10ccBPY-1002017-02-12
M958BSF00075BioSphere Flex SPMediumBSF-000752020-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
03760191134928MectaBlast GranulesNORAKERMQV2026-05-27
03760191134935MectaBlast GranulesNORAKERMQV2026-05-27
03760191134942MectaBlast GranulesNORAKERMQV2026-05-27
M263W21000WizardBio Resorbable Calcium Phosphate CementDSM BIOMEDICAL, INC.MQV2019-01-02
M263W23000WizardBio Resorbable Calcium Phosphate CementDSM BIOMEDICAL, INC.MQV2019-01-02
08719699710122MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710276MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710283MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710290MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710306MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710313MagnetOsKuros Biosciences B.V.MQV2018-01-08
08719699710320MagnetOsKuros Biosciences B.V.MQV2018-01-08