FDA.reportPublic FDA data

Simplex

Primary DI
07613327128451
Brand
Simplex
Company
Howmedica Osteonics Corp.
Model
6192-1-001
Catalog number
6192-1-001
Device description
SpeedSet Full Dose Antibiotic Bone Cement, 10 pack catalog number is 6192-1-010
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
MBBBONE CEMENT, ANTIBIOTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LODBone CementOrthopedic2
MBBBone Cement, AntibioticOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053198000
K063857000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053198000SIMPLEX P SPEEDSET BONE CEMENTHowmedica Osteonics Corp.2006-01-26LOD
K063857000SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENTHowmedica Osteonics Corp.2007-02-26MBB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
37613327128452PackageGS110In Commercial Distribution
57613327128456PackageGS12In Commercial Distribution
07613327128451PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3761332712845237613327128452
5761332712845657613327128456
07613327128451076133271284517613327128451

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
Weight40Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature6 Degrees Celsius23 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
07613327259797INSTRUMENT1100-2800R1100-2800R2016-09-24
07613327138078SOLAR5351-41085351-41082015-09-24
04546540167415EXETER0942-2-1100942-2-1102015-09-24
04546540167422EXETER0942-2-1120942-2-1122015-09-24
04546540167439EXETER0942-2-1140942-2-1142015-09-24
04546540167446EXETER0942-2-1160942-2-1162015-09-24
04546540167453EXETER0942-2-1180942-2-1182015-09-24
04546540167460EXETER0942-2-1200942-2-1202015-09-24
07613327245158INSTRUMENT6543-4-8186543-4-8182017-11-13
07613327660180Instrument5533-T-409-R5533-T-409-R2026-02-27
07613327648386Instrument5533-T-812-R5533-T-812-R2026-02-26
07613327648393Instrument5533-T-811-L5533-T-811-L2026-02-26
07613327648409Instrument5533-T-812-L5533-T-812-L2026-02-26
07613327648416Instrument5533-T-810-R5533-T-810-R2026-02-26
07613327648423Instrument5533-T-816-L5533-T-816-L2026-02-26
07613327648430Instrument5533-T-809-L5533-T-809-L2026-02-26
07613327648447Instrument5533-T-814-R5533-T-814-R2026-02-26
07613327648454Instrument5533-T-809-R5533-T-809-R2026-02-26
07613327648461Instrument5533-T-810-L5533-T-810-L2026-02-26
07613327648478Instrument5533-T-811-R5533-T-811-R2026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887868551611StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551628StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551635StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551659StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551666StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551673StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
00887868551680StageOne SelectBiomet Orthopedics, LLCMBB2026-03-17
08031497003955Interspace GV Hip Spacer 46TECRES SPAMBB2026-02-11
08031497003962Interspace GV Hip Spacer 54TECRES SPAMBB2026-02-11
08031497003979Interspace GV Hip Spacer 60TECRES SPAMBB2026-02-11
08031497003986Interspace GV Hip Spacer 46 XLTECRES SPAMBB2026-02-11
08031497003993Interspace GV Hip Spacer 54 XLTECRES SPAMBB2026-02-11
08031497004006Interspace GV Hip Spacer 60 XLTECRES SPAMBB2026-02-11
03760177044326Signature -x Cement TEKNIMEDMBB2026-01-23
03760177044333Signature -x Cement TEKNIMEDMBB2026-01-23
03760177044340Signature -x Cement TEKNIMEDMBB2026-01-23
03760177040090GENTAFIXTEKNIMEDMBB2025-09-02
03760177040137GENTAFIXTEKNIMEDMBB2025-09-02
03760177043176GENTAFIXTEKNIMEDMBB2025-09-02
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONLOD2024-11-21
08058964728722Arthrex Bone Cement HV w/GG21 SRLMBB2024-09-16
08058964728746Arthrex Bone Cement MV w/GG21 SRLMBB2024-09-16
08058964729019BRAVO MV+GG21 SRLMBB2024-09-16
08058964729026BRAVO HV+GG21 SRLMBB2024-09-16
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