FDA.reportPublic FDA data

Simplex

Primary DI
07613327128420
Brand
Simplex
Company
Howmedica Osteonics Corp.
Model
6197-9-001
Catalog number
6197-9-001
Device description
Tobra Full Dose Antibiotic Bone Cement, 10 pack catalog number is 6197-9-010
Published
2017-06-19
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K014199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014199000SURGICAL SIMPLEX P WITH TOBRAMYCINHowmedica Osteonics Corp.2003-05-06LOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327128421PackageGS110In Commercial Distribution
57613327128425PackageGS12In Commercial Distribution
07613327128420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332712842137613327128421
5761332712842557613327128425
07613327128420076133271284207613327128420

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, antimicrobialA substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic prosthetic implants to the living bone and/or to fill voids in the case of bone pathologies, and to treat infected joint prostheses or osteomyelitis; it may also be used prophylactically in primary or uninfected revision total joint arthroplasty. It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene, and contains an antimicrobial agent. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume20Milliliter
Weight41Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature6 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
058311945
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327036503Triathlon5585-C-0165585-C-0162015-09-24
07613327036510Triathlon5585-C-0205585-C-0202015-09-24
07613327036527Triathlon5585-C-0255585-C-0252015-09-24
07613327036534Triathlon5585-C-0305585-C-0302015-09-24
07613327036541Triathlon5585-C-0355585-C-0352015-09-24
07613327036558Triathlon5585-C-0405585-C-0402015-09-24
07613327036565Triathlon5585-C-0455585-C-0452015-09-24
07613327036572Triathlon5585-C-0505585-C-0502015-09-24
07613327036589Triathlon5585-C-0555585-C-0552015-09-24
07613327036596Triathlon5585-C-0605585-C-0602015-09-24
07613327041071Triathlon5520-M-1005520-M-1002015-09-24
07613327041095Triathlon5520-M-2005520-M-2002015-09-24
07613327041101Triathlon5520-M-3005520-M-3002015-09-24
07613327041118Triathlon5520-M-4005520-M-4002015-09-24
07613327041125Triathlon5520-M-5005520-M-5002015-09-24
07613327041132Triathlon5520-M-6005520-M-6002015-09-24
07613327041149Triathlon5520-M-7005520-M-7002015-09-24
07613327041156Triathlon5520-M-8005520-M-8002015-09-24
07613327041392Triathlon5527-B-1005527-B-1002015-09-24
07613327041408Triathlon5527-B-3005527-B-3002015-09-24

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