FDA.reportPublic FDA data

BonOs R 1x40

Primary DI
04260056885624
Brand
BonOs R 1x40
Company
OSARTIS GmbH
Model
01-0117
Device description
BonOs® R is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. BonOs® R cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. BonOs® R does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
Published
2015-09-25
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

Product Codes#

Code, Name table
CodeName
LODBone Cement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LODBone CementOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14260056885621PackageGS120In Commercial Distribution
04260056885624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1426005688562114260056885621
04260056885624042600568856244260056885624

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, non-antimicrobialA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight40Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature17 Degrees Celsius25 Degrees Celsius
Special Storage Condition, Specify00Store between 0°C (32°F) and 25°C (77°F)

Regulatory Flags#

DUNS number
344261631
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260056880674XPERIENCE Advanced Surgical IrrigationSL-0005MC-SL-0005-102026-04-01
04260056880643BLASTX®WG-0001MC-WG.0001-122026-02-19
14260056880640BLASTX®WG-0001MC-WG.0001-122026-02-19
04260056882579BonOs HV1x4001-01622024-05-17
04260056882623BonOs HV Genta1x4001-02622024-04-03
04260056880759Vertecem II Cement Kit08.702.017S08.702.017S2015-10-21
04260056883231BonOs Inject01-03092015-10-02
04260056880612EASYMIX® Nozzle slim02-010402-01042022-12-01
04260056880919EASYMIX® Nozzle revision02-010502-01052022-12-01
14260056880619EASYMIX® Nozzle slim02-010402-01042022-12-01
14260056880916EASYMIX® Nozzle revision02-010502-01052022-12-01
04260056881022EASYMIX® compressed air hose02-020502-02052022-12-01
04260056881039EASYMIX® compressed air hose02-020602-02062022-12-01
04260056881633EASYMIX® vacuum pump I02-040102-04012022-12-01
04260056881930EASYMIX® vacuum pump II02-020102-02012022-12-01
04260056881251EASYMIX cement injector02-0504-0402-0504-042022-11-28
04260056884412EASYMIX pro02-030502-03052021-11-11
04260056884429EASYMIX pro02-030502-03052021-11-11
04260056881565ManuMix02-060102-06022021-10-12
04260056881572ManuMix02-060102-06022021-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760177044326Signature -x Cement TEKNIMEDLOD2026-01-23
03760177044333Signature -x Cement TEKNIMEDLOD2026-01-23
03760177044340Signature -x Cement TEKNIMEDLOD2026-01-23
04260102139411OSTEOPAL®Heraeus Medical GmbHLOD2025-09-26
04260102139428OSTEOPAL®Heraeus Medical GmbHLOD2025-09-26
03760177040090GENTAFIXTEKNIMEDLOD2025-09-02
03760177040137GENTAFIXTEKNIMEDLOD2025-09-02
03760177043176GENTAFIXTEKNIMEDLOD2025-09-02
07898315500901Bone Cement - Normal ViscosityBiomecânica Indústria e Comércio de Produtos Ortopédicos Ltda.LOD2025-04-23
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONLOD2024-11-21
08058964729033Arthrex Bone Cement HVG21 SRLLOD2024-10-04
08058964729040Arthrex Bone Cement MVG21 SRLLOD2024-10-04
08058964728647Arthrex Bone Cement HVG21 SRLLOD2024-09-16
08058964728678BRAVO HVG21 SRLLOD2024-09-16
08058964728722Arthrex Bone Cement HV w/GG21 SRLLOD2024-09-16
08058964728739Arthrex Bone Cement MVG21 SRLLOD2024-09-16
08058964728746Arthrex Bone Cement MV w/GG21 SRLLOD2024-09-16
08058964729002BRAVO MVG21 SRLLOD2024-09-16
08058964729019BRAVO MV+GG21 SRLLOD2024-09-16
08058964729026BRAVO HV+GG21 SRLLOD2024-09-16
04260056882579BonOs HVOSARTIS GmbHLOD2024-05-17
04260056882623BonOs HV GentaOSARTIS GmbHLOD2024-04-03
03770007907752V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907769V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907776V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907783V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907790V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907806V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907813V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27
03770007907820V-STRUT Vertebral ImplantHyprevention Inc.LOD2024-02-27