FDA.reportPublic FDA data

Refobacin® Bone Cement R

Primary DI
00880304990197
Brand
Refobacin® Bone Cement R
Company
BIOMET
Model
110034355
Catalog number
110034355
Published
2018-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K171540000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171540000Refobacin Bone Cement RBiomet, Inc.2017-08-30LOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304990197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304990197008803049901978803049901970880304990197

Contacts#

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

Regulatory Flags#

DUNS number
260930126
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304810990Cement Delivery System1100306231100306232020-04-15
07350023771719Cement Delivery System414641462021-04-27
00887868214578BIOMET® BONE CEMENT R1100353681100353682018-04-04
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
00880304990203REFOBACIN® BONE CEMENT R1100343561100343562018-03-30
00880304990210REFOBACIN® BONE CEMENT R1100343571100343572018-03-30
00880304990227REFOBACIN® BONE CEMENT R1100343581100343582018-03-30
07350023771788Optigun Ratchet4195004195002020-05-23
03599870107898TESS BASEA1700380A17003802020-05-23
03599870108505T.E.S.S® LIDA1700382A17003822020-05-23
08428898898332TESS BOTTOM INSERT HEMIA1700384A17003842020-05-23
08428898898349TESS TOP INSERT HEMIA1700386A17003862020-05-23
00880304370562Optivac Total Hip Kit4170004170002017-10-09
00880304370579Optivac Kit, 40 gram single Mix4171004171002017-10-09
00880304370609Optivac Kit, 80 gram Double Mix4172004172002017-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260056885860InterSpace® Hip Mold Short StemOSARTIS GmbHMBB2026-10-29
04260056885884InterSpace® Hip Mold Short StemOSARTIS GmbHMBB2026-10-29
04260056885907InterSpace® Hip Mold Short StemOSARTIS GmbHMBB2026-10-29
04260056885921InterSpace® Hip Mold Long StemOSARTIS GmbHMBB2026-10-29
04260056885945InterSpace® Hip Mold Long StemOSARTIS GmbHMBB2026-10-29
04260056885969InterSpace® Hip Mold Long StemOSARTIS GmbHMBB2026-10-29
04260056885983InterSpace® Hip Mold HeadOSARTIS GmbHMBB2026-10-29
04260056886003InterSpace® Hip Mold HeadOSARTIS GmbHMBB2026-10-29
04260056886027InterSpace® Hip Mold HeadOSARTIS GmbHMBB2026-10-29
04260056886041InterSpace® Hip Mold HeadOSARTIS GmbHMBB2026-10-29
04260056886065InterSpace® Hip Mold HeadOSARTIS GmbHMBB2026-10-29
04260056886089InterSpace® Knee Mold Femoral Component XSOSARTIS GmbHMBB2026-10-29
04260056886102InterSpace® Knee Mold Femoral Component SOSARTIS GmbHMBB2026-10-29
04260056886126InterSpace® Knee Mold Femoral Component MOSARTIS GmbHMBB2026-10-29
04260056886140InterSpace® Knee Mold Femoral Component LOSARTIS GmbHMBB2026-10-29
04260056886164InterSpace® Knee Mold Femoral Component XLOSARTIS GmbHMBB2026-10-29
04260056886188InterSpace® Knee Mold Tibial Component XSOSARTIS GmbHMBB2026-10-29
04260056886201InterSpace® Knee Mold Tibial Component SOSARTIS GmbHMBB2026-10-29
04260056886263InterSpace® Knee Mold Tibial Component XLOSARTIS GmbHMBB2026-10-29
04260056886225InterSpace® Knee Mold Tibial Component MOSARTIS GmbHMBB2026-10-28
04260056886249InterSpace® Knee Mold Tibial Component LOSARTIS GmbHMBB2026-10-28
10603295518761SMARTSETDEPUY (IRELAND)LOD2026-09-10
10603295518761SMARTSETDEPUY (IRELAND)MBB2026-09-10
03760177044326Signature -x CementTEKNIMEDMBB2026-01-23
03760177044326Signature -x CementTEKNIMEDLOD2026-01-23
03760177044333Signature -x CementTEKNIMEDMBB2026-01-23
03760177044333Signature -x CementTEKNIMEDLOD2026-01-23
03760177044340Signature -x CementTEKNIMEDMBB2026-01-23
03760177044340Signature -x CementTEKNIMEDLOD2026-01-23
04260102139411OSTEOPAL®Heraeus Medical GmbHLOD2025-09-26