FDA.reportPublic FDA data

BIOMET® BONE CEMENT R

Primary DI
00887868214578
Brand
BIOMET® BONE CEMENT R
Company
BIOMET
Model
110035368
Catalog number
110035368
Published
2018-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LODBONE CEMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LODBone CementOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172408000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172408000Biomet Bone Cement RBiomet, Inc.2017-10-05LOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868214578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868214578008878682145788878682145780887868214578

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement, non-medicatedA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+0330475759100eufrvra@zimmerbiomet.com

Regulatory Flags#

DUNS number
260930126
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304810990Cement Delivery System1100306231100306232020-04-15
07350023771788Optigun Ratchet4195004195002020-05-23
07350023771719Cement Delivery System414641462021-04-27
03599870107898TESS BASEA1700380A17003802020-05-23
03599870108505T.E.S.S® LIDA1700382A17003822020-05-23
08428898898332TESS BOTTOM INSERT HEMIA1700384A17003842020-05-23
08428898898349TESS TOP INSERT HEMIA1700386A17003862020-05-23
00887868214608BIOMET® BONE CEMENT R1100353711100353712018-04-04
07350023771092Optivac Nozzle Slim415441542019-10-11
07350023771108Optivac Nozzle Revision415541552017-10-09
07350023771214Knee Cementation Nozzle431243122017-10-09
07350023771429Angled Nozzle414941492017-10-09
00880304370326Right-Angle Nozzle4149004149002017-10-09
00880304370562Optivac Total Hip Kit4170004170002017-10-09
00880304370579Optivac Kit, 40 gram single Mix4171004171002017-10-09
00880304370609Optivac Kit, 80 gram Double Mix4172004172002017-10-09
00880304370623Optivac Kit, 120 gram Triple Mix4173004173002017-10-09
00880304370647Optivac Total Hip Kit4180004180002017-10-09
00880304370999Optivac Kit, 80 gram Double Mix4182004182002017-10-09
00880304371002Optivac Kit, 120 gram Triple Mix4183004183002017-10-09

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