FDA.reportPublic FDA data

FINN KNEE SYSTEM

Primary DI
00880304649293
Brand
FINN KNEE SYSTEM
Company
Biomet Orthopedics, LLC
Model
RD108806
Catalog number
RD108806
Published
2015-11-18
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KROPROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910877000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910877000FINN KNEE PROSTHESISBiomet, Inc.1991-07-26KRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304649293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304649293008803046492938803046492930880304649293

GMDN Terms#

Term, Definition table
TermDefinition
Uncoated knee tibia prosthesis, metallicAn implantable device designed to replace the tibial condyles (tibial component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with an insert and/or the femoral prosthetic component of the knee joint and its implantation is intended to be performed with bone cement.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304533424DVR® CrosslockWIDE PLATE RIGHT (HEAD WIDTH x OVERALL LENGTH)1318130501318130502015-10-24
00889024707726SolidLok®2810-01-0212810010212026-06-10
00887868561368VersaNail®2810-13-0372810130372023-09-07
00889024707061A.L.P.S.®2142-35-0072142350072026-05-11
00889024707078DRILL BIT2312002012312002012026-05-11
00889024707085DRILL BIT8290-29-0708290290702026-05-11
00880304410541FIBER OPTICS FOR RC RETRACTOR9085349085342019-06-11
00880304321946BIFURCATED FIBER OPTIC CABLE31-55550231-5555022017-07-28
008803044639124MM X 9FT. LIGHT CABLE9061179061172017-07-28
00889024707054CALIBRATED DRILL BIT2142-27-0702142270702026-04-27
00880304233102Biomet® Knee System1418721418722015-10-24
00880304233126Biomet® Knee System1418741418742015-10-24
00880304233140Biomet® Knee System1418761418762015-10-24
00880304233164Biomet® Knee System1418781418782015-10-24
00880304233171Biomet® Knee System1418801418802015-10-24
00880304233188Biomet® Knee System1418821418822015-10-24
00880304433403Vanguard® Knee System1841441841442015-10-24
00880304433410Vanguard® Knee System1841811841812015-10-24
00880304433564Vanguard® Knee System1842851842852015-10-24
00880304433984Vanguard® Knee System1842801842802015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B278AM25002200C0ELEOS™ Limb Salvage System with NanoCept® TechnologyONKOS SURGICAL, INC.KRO2026-06-09
10603295529712ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529729ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529736ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529743ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529750ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529767ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529774ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529781ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529798ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529804ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529811ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529828ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529835ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529842ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529859ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529866ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529873ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529880ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529897ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529903ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529910ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529927ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529934ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529941ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529958ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529965ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529972ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529989ATTUNEDEPUY (IRELAND)KRO2025-10-31
10603295529996ATTUNEDEPUY (IRELAND)KRO2025-10-31