FDA.reportPublic FDA data

BI-ANGULAR SYSTEM

Primary DI
00880304009622
Brand
BI-ANGULAR SYSTEM
Company
Biomet Orthopedics, LLC
Model
114022
Catalog number
114022
Published
2015-10-24
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
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032895000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032895000BI-ANGULAR SHOULDER SYSTEMBiomet, Inc.2003-11-20MBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304009622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304009622008803040096228803040096220880304009622

GMDN Terms#

Term, Definition table
TermDefinition
Stem-fixed humeral head prosthesisA sterile implantable artificial substitute for a diseased or injured humeral head. It is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and designed to be attached to a humeral stem prosthesis and to articulate with the natural glenoid fossa, a glenoid fossa prosthesis, or a humeral head bipolar component as part of a shoulder replacement.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
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
00880304434356Vanguard® Knee System1842651842652015-10-24
00880304434363Vanguard® Knee System1842701842702015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.MBF2026-05-28
08033390002233SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390002240SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390002257SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390050029SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390050036SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390115667SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390115711SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121484SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121507SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121514SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121521SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121545SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121569SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121583SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121590SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121613SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121637SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121644SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121668SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121682SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121699SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121927SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121972SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390121989SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122009SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122023SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122030SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390122047SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390153119SMR ShoulderLIMACORPORATE SPAMBF2024-07-26